IA #66-41 - 5/11/07 REVISION OF IMPORT ALERT #66-41 "DETENTION WITHOUT
PHYSICAL EXAMINATION OF UNAPPROVED NEW DRUGS PROMOTED IN THE U.S." ATTACHMENT
A REVISED 12/1/08, ATTACHMENT B REVISED 1/23/07
NOTE: The revision dated 5/10/2007 adds a charge for misbranded drugs.
Relevant edits are bracketed by asterisks (***).
TYPE OF ALERT: Detention Without Physical Examination (DWPE)
(Note: This import alert contains guidance to FDA field
personnel only. It does not establish any requirements, or
create any rights or obligations on FDA or on regulated
entities.)
PRODUCT: Unapproved new drugs, *** Misbranded drugs ***
PRODUCT
CODE: See attachment
PROBLEM: Unapproved drugs *** and/or misbranded drugs *** promoted in
the U.S.
OASIS
CHARGE CODE: UNAPPROVED, *** MISBRANDED ***
PAF: AAP (Approvals)
PAC: 56008H
63001
SHIPPER: See attachment
REFERENCE: Regulatory Procedures Manual Chapter 9, Subchapter "Coverage
of Personal Importations" issued 2/11/89. (Note: This
subchapter, previously designated as RPM 9-71, was issued to
consolidate guidance that previously existed in RPM
Chapters: 9-71, "Mail Importations" and Chapter 9-72,
"Coverage of Importations Contained in Personal Baggage,"
and the Pilot Guidance for Release of Mail Importation dated
July 29, 1988.)
Compliance Policy Guide (CPG) 120.500 (formerly 7150.10)
gives extensive background on health fraud, and the indirect
risks of relying on unproven remedies. Health fraud has
been defined by the agency as the promotion of unproven
medical products.
CHARGE: "The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to be a new drug within
the meaning of Section 201(p) without an effective new drug
application (NDA)[Unapproved New Drug, Section 505(a)]".
*** When unaccompanied by labeling which makes drug claims,
but other evidence attributable to the manufacturer, owner,
or consignee exists which establishes the product's intended
use as a a drug, charge:
"The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to be a drug within the
meaning of Section 201(g) and it lacks adequate directions
for use. [Misbranded, Section 502(f)(1)]". ***
RECOMMENDING
OFFICE: Division of Import Operations and Policy (HFC-170)
*** Center For Drug Evaluation and Research, Office of
Compliance (HFD-300) ***
REASON FOR
ALERT: Media reports concerning FDA's guidance for release of
importations for personal use have inaccurately suggested
that any unapproved drug may be imported through the mail
for personal use. The pilot guidance and subsequent
Regulatory Procedures Manual Subchapter, "Coverage of
Personal Importations," that issued is much more restrictive
than reported. The RPM subchapter provides guidance for use
in those instances in which field personnel determine that
the exercise of discretion regarding the admissibility of an
unapproved drug might be appropriate. The guidance is by its
very terms discretionary, and does not provide anyone with a
right to import any drug.
The guidance provides that release of an unapproved drug for
personal use may be appropriate if, among other
considerations, the drug is intended for a serious condition
for which effective treatment may not be available
domestically either through commercial or clinical means,
and it is not considered to represent an unreasonable risk.
The guidance is intended to apply only to: (1) persons who
have received treatment in a foreign country with an
unapproved drug which is not available in the United States,
and who, upon returning to the United States, have imported
the drug for their personal use in an effort to continue the
treatment started abroad; and (2) persons who have made
their own arrangements for obtaining an unapproved drug from
foreign sources, when the drug has not been promoted in the
United States.
When there is evidence of promotion of unapproved drugs to
persons in the United States, the products should be
considered for detention. Evidence of promotion may consist
of solicitations for mail orders, press releases,
advertising materials, and other public announcements that
are directed to persons residing in the U.S.
The subchapter of the RPM on coverage of personal
importations provides guidance for FDA personnel on when it
is appropriate to recommend import alerts involving
unapproved products likely to be imported for personal use.
Such recommendations are appropriate when an unapproved
product represent a health fraud, as defined in CPG 120.500
or an unapproved foreign product is promoted for mail-order
shipments. Thus, the field may recommend detain without
physical examination when an unapproved *** and/or
misbranded *** product poses either a direct health risk or
indirect health risk.
GUIDANCE: Districts may detain without physical examination any
Unapproved *** and/or misbranded drug *** listed in the
attachment.
Districts may also detain without physical examination any
other unapproved *** and/or misbranded *** drug that fails
to meet the discretionary release criteria in the RPM. ***
Contact CDER Import-Export Team before detaining any OTC
product that appears to only meet the misbranding criteria
and would therefore be detained on misbranding charges
exclusively. *** When detained products appear to meet these
criteria are not listed in the attachment, districts should
forward documentation to DIOP for consideration for
inclusion in this alert.
SPECIAL NOTE: Districts should continue to enforce, as appropriate,related
import alerts restricting fraudulent, dangerous and
commercial unapproved *** and/or misbranded *** drug
importations.
FOI: No purging required.
KEYWORDS: New drugs, unapproved new drugs, *** misbranded drugs ***
PREPARED BY: DIOP, Operations and Policy SDWG: HFC-172, (301) 443-6553
*** Center For Drug Evaluation and Research, Office of
Compliance (HFD-300) ***
DATE LOADED
INTO FIARS: May , 2007
ATTACHMENT A TO IMPORT ALERT #66-41 12/1/08
*** Unapproved and/or misbranded new drugs that may be subject to DWPE ***
Although Gamma Hydroxybutyrate (GHB) has been identified as an unapproved new
drug and covered in this import alert, effective March 13, 2000, GHB was
classified as a Schedule I Controlled Substance and under DEA authorization.
Therefore, entries of GHB, or its analogue GBL should be returned to Customs
for appropriate disposition. (GBL and related substances can be treated as
controlled substance analogues, and as Schedule I Controlled Substances, if
intended for human consumption).
Manufacturer Product/Product Codes
Chempropack BV "G-Spot"
Donker Duyvisweg 45 65V50 and 65V51
Dordrecht, 3316 BL, Netherlands GPI = VI
FEI# 3002854125 3/30/00
Products shipped by the following firms were found to contain the drugs
glyburide and phenformin, which are used to treat diabetes. These products,
being promoted as dietary supplements claiming to contain only natural Chinese
herbal ingredients, are available through mail order and can be purchased by
telephone or via the Internet. These `products are being recalled under a
Class I recall as a health hazard.
PRODUCT SOURCE COUNTRY
Ayurvedic Fair and Lovely Cream Hindustan Lever Ltd. India
53L[][]03 Dag No 21 of 122 F.s. grant
11/3/06 Mouza-tingra
Doomdooma Industrial Estate, Off Nh-37
Ayurvedic Fairness Cream Mumbai, India
53L[][]03 FEI# 3004356927
11/3/06
All Products Harbin Dong Fang International China
GPI = DR Trading Corp.
GPI = VI No. 68 Dong Feng St. Dist. Harbin
2/24/00 Aphin, China
FEI# 3002158294
All Products China Hua Yang Technology & Trade China
GPI = DR Corp.
GPI = VI No. 13, South Xin Hua St., He Ping Men
2/24/00 Beijing 10052, China
FEI# 1000280039
PRODUCT SOURCE COUNTRY
"Alpecin Special" Continental Cosmetics, Ltd. Canada
Vitamin Hair 390 Millway Ave.
Lotion Concord, Ontario,
L4K 3V8 (Shipper)
Canada
MID #XOCONCOS390CON
Alcina Bielefeld Germany
(Manufacturer)
MID #DEALCBIE
Alcina Cosmetic Belus
BVBA/SPRL
Spaoi s.r.l.
GE, Italia Italy
(Distributor)
MID #ITALCCOSGEN
Alcina Cosmetic Netherlands
Nederland B V (Distributor)
MID #NLALCCOSUNK
Calfcart Attogram Corp. Canada
(calf cartilage 12295 Hwy 50, RR #3
cream) Bolton, Ontario
8/19/94 MID# CAATTCOR1229BOL
PRODUCT SOURCE COUNTRY
"Crino Pouss" Altesse Cosmetique, Inc. Canada
Capillary Serum BP452BR
with Placenta Montreal, Que. Canada
H2S 3M3 Canada
MID #XQALTCOS452MON
Buffalo district recently detained two hair lotions products which were
labeled with claims of anti-hair loss. The district detained the products
based on violation of 21 CFR 310.527(b) in that the products were represented
as external hair loss prevention lotions which is regarded as a new drug
within the meaning of section 201(p) for which a new drug application (NDA)
under section 505 is required for marketing.
The shipments were commercial size entries which appeared to be for
distribution and sale in the U.S.
Dextran Sulfate Polydex Pharmaceuticals, Ltd. Canada
"Formula 101" Manufacturer: China
"Beijing Zhangguang" General Factory of
Hair Regrowth Liniment Beijing Zhangguang Hair
Regrowth Liniment 725, Area 7, Jim Song Xi,
Chagyang, Beijing, China
Shipper: Canada
International
Health Organization
(aka - R&R International)
Cornwall, Ontario, Canada
Kamagra (Sildenafil Ajanta Pharma Limited India
100 mg. oral tablet) 318 Linking Road
65PD[]02 Mumbai, India
04/4/03 FEI #1000446587
Laetrile All Firms All Countries
also known as: amygdalin,
Vitamin B-17 (100 mg & 500 mg tablets),
and "amigdalina" (ampules for injection)
Product Codes: 54E15, 54F15, 54Y05
01/14/00
Promoter/Distributor Canada
Life Crystals, Dr. Ravi Devgan
oral 32 oz. Life Crystals,
5 cc I.V. Chondriana, (dba: The Total Wellness Center
6 cc I.V. 42 Redpath Avenue
Immumostim LV047 Toronto, Ontario, Canada, M4S 2J6
MID# XORAVDEG42TOR
METBAL
Metabolic Balance
vitamin Metabolic balancing
serum used for a verity of
conditions such as cancer,
diabetes, lupus, etc.
AND
PRODUCT SOURCE COUNTRY
Organotherapy- The Total Wellness Center Canada
(Live Cell 21219 Woodbine Avenue
Fractions Therapy) R.R. 1, Queensville, Ontario
Shark cartilage) L0G 1R0
CAR-T-Cell Canada
Natcell M - mesenchyme MID# XOTOTWEL2121QUE
Natcell C- cerebrum
Natcell T - thymus
AND
Distributor
NaturPharm Inc.
Address Unknown
AND
Promoter
Dr. George Merkl, President Canada
Consumer Health Organization
of Canada
250 Sheppard Avenue
Willowdale, Ontario,
M2N 5S9, Canada
AND
Distributor
Life Crystals Dr. Villalpando Mexico
Address Unknown
(Note: Some or all of the above identified products are perhaps being shipped
by the shippers/distributors/promoters so identified)
All the above products are reported to be used in a treatment regimen promoted
by The Total Wellness Centers, one of which is operated by Dr. Ravi Devgan.
Available literature promotes the procedure as effective for the treatment of
AIDS, Epstein Barr Virus and cancer, by cleansing the blood. A video tape,
entitled "New Frontiers in Molecular Biology Life Crystal Capturing the Sun"
promotes use of these products and is narrated by Dr. Merkl, who is also the
President of ^
^.
Cancer treatment - Drogueria Samuel Hahneman Colombia
(Product purportedly Fundacion Palcossio
made from extracts of Carrera 42 E. NO. 88-20
turkey-buzzard Barranqiulla, Colombia
(vulture) and
reinforced with 333
anticancer plants.
All Drugs International Products West Germany
7000 Stuttgart 1
*Adrenal cortex All All
extract
PRODUCT SOURCE COUNTRY
*(It should be noted that these products are also covered under Import Alert
#66-08 "Drug Products Containing Adrenal Cortex Extract or Adrenal Cortex
Injection".)
*Adrenal cortex All All Injection
All Drugs Interlab, Luzerner Str. 28 Switzerland
CH-6330-CHAM-2G
Interlab, Serco Ex Via
Cantonale 42, CH-6948
Porza-Lugano
Interlab, Newport, England England
Pagnell, Bucks MK 16 8AA
All Drugs Pharmaceutical International Mexico
Artrilan Tablets Offenbach Mexicana Mexico
(contains prednisone,
salicylamide, and
meprobamate)
Zone Generators All All
Polyerga HorFerVit West Germany
Pharma GMBH
Hormone Fermente
Vitamine
Wehdestrabe 16
D-2900 Oldenburg,
West Germany
Zellen Live Cell Zellen Cell Pharmaceuticals Mexico
Therapy (and all Apartado Postal No. 1118 (10/22/92)
other products) Tijuana, B.C. Mexico
C.P. 22000
Zellyn Cell Research Oxygenesis Live Cell Therapy Bermuda
P.O. Box HM 1120 (and all other products) (4/21/94)
Hamilton, HMEX Bermuda
MID# BMZELCEL1120HAM
***Energy Complex*** A.G.E.S. Distribuidora Mexico
Apartado Postal No. 2603
Tijuana, B. C., Mexico
C.P. 22000
ID# MXAGEDIS2603TIJ
Nutri-Mail Mexico
Apartado Postal No. 8-F 6/19/96
Tijuana, B.C., Mexico 22540
MID# MXNUT8TIJ
***Note: Product may also be shipped from Inter-Medica of Tijuana, B.C.,
Mexico. This firm was identified for similar promotion in Bulletin IB#66-08,
10/26/87, for Neutralizer G.H, a weight loss product.***
PRODUCT SOURCE COUNTRY
Beta-Interferon CORNE,S.A. de C.V. Mexico
(Trade name FRONE TM) Rio San Lorenzo No. 623
(Alternate names- Col. Puentes del Valle
Rebif (TM) Garza Garcia, Nuevo Leon
R-FRONE ) 66220, Mexico
Manufacturer:
Serono Laboratories
Mexico
SAN-DO received promotional literature for the purchase of the above
referenced product. The literature identifies the product for the treatment
of Multiple Sclerosis and implies it is similar to the approved Interferon
beta-1b approved for use in the U.S.
The product is shipped via UPS upon receipt of a doctor's prescription. The
shipment includes FRONE TM 3,000,000 U.I. with dilutent, etc. for $200.
Information from the manufacturer of the approved Beta-Interferon to be sold
in the U.S., indicates this product appears to be half the strength of the
U.S. recommended therapeutic dose.
MIN-DO received promotional literature for the purchase of the above
referenced product from A.G.E.S. Distribuidora, Mexico. The literature
identifies the product as a "sexual breakthrough"; "potential benefits are:
Immediate energy and vigor, Reverses impotence in men of any age, ***"; "from
limp, standstill impotence to virility in as little as 48 hours"; etc.
Discretionary release of unapproved drug products promoted to individuals in
the U.S. is unacceptable under the Personal Importation Guidance of Regulatory
Procedures Manual Chapter 9-71.
All Drugs A. Werner & Co. Czechoslovakia
P.O. Box 615 9/23/93
111 21 Prague 1
Czechoslovakia
MID #: CSWERCO615PRA
All products Lenex Labs
Wavecrest House
West Bay St.
P.O. Box N-8174
Nassau, Bahamas
U.S. Distributor:
Alpha Omega Labs
Box 291
Fort Benton, Montana 59442
Boston District received promotional literature and mail order solicitation
for drugs from Alpha Omega Labs. The materials accompanied a letter from
Lenex Labs, in which Lenex stated that Alpha Omega would service orders on
Lenex's former products. The firms offer a variety of products, including
cancer inhibitors, weight loss products, and treatment for toxic bowel
symptoms.
PRODUCT SOURCE COUNTRY
*** All Drug Products Gero Vita International Canada
2255 B Queen Street East, Suite 820 4/6/95
Toronto, Ontario M4E 1G3 Updated
Canada 8/18/97
MID# XOGERVIT2255TOR
FEI# 1000327472
Gero Vita International (may be doing business as)
Life Force Laboratories 12/5/97
2255 B Queen Street East, Suite 820
Toronto, Ontario M4E 1G3
Canada
FEI# 3001190383
Gero Vita Laboratories 11/4/97
130A Denison Street
Markham, Ontario, Canada L3R 1B6
FEI# 30001146884
***NOTE: Gero Vita Laboratories is currently listed on the attachment to
import alert 66-41 for their promotion and distribution of "Prostata".
Evidence has been provided to FDA which indicates the firm is also promoting
and distributing to individuals in the U.S. numerous other drug products
(including but not limited to: GH3 (enhances memory);Testerex (enhances
sexual vitality); SOD Complex (fights disease causing free-radicals);
Medi-Zyme N (anti-inflammatory); Serezac (helps alleviate depression); Lung
Support Formula (moistens lungs & breaks up sputum; strengthens kidneys); Vita
Potencia (protects heart health; helps control stress); ACF 223 (reduces risk
of heart disease, cancer);etc.) which would be considered unapproved new
drugs.
Gero Vita Laboratories 2/14/00
4936 Yonge Street
Toronto, Ontario, Canada M2N 6S3
FEI# 3002084064
Quantrol I Quantrol Research Institute Dominican
Quantrol II Ave. Sarasota Edificio Republic
(or CanCell) Embajador Edif. E, 8-I 12/22/95
(May be invoiced as Santo Domingo 99999
water) Dominican Republic
PRODUCT CODE: 62I99 aka Quantrol Agency or Quantum Research
INTERNATIONAL TRADE Live Cell Therapy Mexico
Apartado Postal No. 81 GPI=DR 2/9/96
Admon. de Correos Mesa De Otay
Mexico CP 22500
MID:MXINTTRA81ADM
FEI:1000481446
Information submitted to DIOP by ATL-DO indicates the above firm is soliciting
individuals to purchase Live Cell Therapy. The product is currently on import
alert from other shippers and under the name of Zellen Live Cell Therapy. The
Live Cell Therapy is being promoted for numerous medical conditions, including
aging problems, lack of energy, impotency, diabetes, degenerative brain
disease, etc. Promotion is usually accompanied by a MEMO FROM DR. HANZ BYRON
PREMATURE AGING SPECIALIST, HOLISTIC HEALTH CENTER LONDON, ENGLAND, ZURICH,
SWITZERLAND.
OTC-TRANSDERMAL PATCHES ALL ALL
FOR WEIGHT CONTROL 8/6/96
There has been an increase in the promotional advertising for OTC transdermal
patch products claiming they are effective for weight control. Health Fraud
Bulletin #13, dated February 3, 1989, regards OTC transdermal patch drug
products as unapproved new drugs and misbranded drugs, because of the method
of administration. (DRND/MLLM) (Product Code-66V[][]99)
(Note: Nicotine transdermal patch drug products are now acceptable for OTC
marketing via approved NDAs)
(Note: One firm in Canada has been identified as currently promoting such
patches-United Research Center, 1414 Place Bonaventure, Montreal, Quebec,
Canada, H5A 1H3 (FEI #1000595188,
MID #XQUNIRES1414MON) under the name of "The Svelt Patch")
PRODUCT SOURCE COUNTRY
All over-the-counter (OTC) vaginal 65X[][]01, 65X[][]02,
contraceptive drug products (including 65X[][]03, 65X[][]04,
contraceptive sponges) NOT labeled for 65X[][]99
"immediate use" (immediate use = less 6/16/97
than one hour prior to intercourse) and
not the subject of an approved new
drug application (NDA).
Liquid Deprenyl Citrate Discovery Experimental and Mexico
(Finished product) Development Mexico, N.A. 7/1/97
Juan Carrisco no. 13
GPI = DR Tijuana, B.C., Mexico
FEI# 3000326275
AND
Deprenyl (bases and salts) All Sources All Countries
(common name = selegilene) 62J[][]99, 66Y[][]99 7/21/97
or similar anti-parkinson products
Ephedrine Hydrochloride Tablets Sun Labs. Ltd. Canada
60C[][]22 1700-1700 McLeod Road 9/16/97
Niagara Falls, Ontario, Canada
L2G 7K3
FEI# 3000928033
ALL IAS Ltd. Great Britain
P.O. Box 2995 10/17/97
Muswell Hill
London N10 2NA
Great Britain
FEI #3001047710
aka: Int'l Antiaging Systems
P.O. Box 337
Guernsey, Channel Islands
Great Britain
Super Concentrated Aloe Vera WLA 132 The Wolfe Clinic Canada
C-Max 5 Scotsville Road 12/17/97
Coral Calcium & Coral Calcium Gold Strathlorne, Nova Scotia
Cesium Calcium FEI# 3001109438
PRO-MAX PRODUCT CODE: 66V[][]99
Pak-of-Life
ANTI-AGING PILL (Multitabs) Conseils De Sante, S.A. Switzerland
PRODUCT CODE: 66V[][]99 P.O. Box 331 1/27/98
1211 Geneva 12
Switzerland
FEI# 3001366101
This product contains deprenyl, vinpocetin, ergoloid mesylates (hydergine),
procaine HCl, and hematoporphyrin.
OSMOPAK PLUS (Manufacturer - per label) Canada
61MBJ11 Laboratoire Charton Laboratories 3/26/98
Division Herdt & Charton Inc.
9393 Louis H. Lafontaine
Montreal, Quebec, Canada
FEI# 1000541169
PRODUCT SOURCE COUNTRY
(Shipper)
Distribution Rapiflex
759 Marie-Victorin
St. Bruno, Quebec, Canada
FEI# 3001019316
This product is used as a drawing salve for the inflammation of subcutaneous
tissues.
BM Oral Solution, Xiehe Group Co., Ltd. China (Mainland)
and any product 19-A-8 Sanhac Street 4/1/98
containing the Shenyang, Liaoning
ingredient China (Mainland)
Staphylococcin FEI #3001281354
Prescription Vitality Health Products Thailand
Drugs: C/O Nimit Pharmacy 8/13/98
Dexfenfluramine944 Rama 4 Road
Medroxyprogesterone Bangkok
Premarin Thailand
66V[][]99 FEI #3001715829
QUINICRINE HYDROCHLORIDE ALL FOREIGN All
FINISHED PRODUCT/ALL MANUFACTURERS 8/25/98
FORMS-TABLETS,
(CAPSULES, LIQUID, ETC./
(NOT BULK/RAW MATERIAL)
PRODUCT CODE-60W[][]34
Dermopura Acneiche Revivre Cosmetiques C.R.B. spa Italy
Treatment against Acne & Via Vallina Orticella, 34 12/3/98
scarring.(Product maybe 31030 Borso Del Grappa (TV),Italy
entered as a Cosmetic under FEI #1000484992
PC(53LC-03) As a drug
treatment it may be
entered as PC 64X--07
or 99 (acne drug products)
or as 66V--99 (Miscel. Patent Medicines)
NOTE: CDER has determined this product is being marketed over the internet and
promoted for use as a treatment against "acne and scarring". The active
ingredients listed include "azelaic acid". That ingredient offered as an OTC
acne treatment, is a new drug, requiring an NDA to obtain marketing
authorization and should not be promoted as an OTC product. This product also
appears to be in violation of the final rule (21 CFR section 333.301) covering
acne products. Questions regarding this product or other similar products
should be addressed to Constance E. Bulawka, OTC Compliance Branch, Division
of Drug Labeling and Nonprescription Drug Compliance, HFD-312, 301-594-1065.
PLEASE ADD THE ABOVE FIRM/PRODUCT TO THE ATTACHMENT OF IMPORT ALERT #66-41.
PRODUCT SOURCE COUNTRY
Serotril Sciences, International "Serotril"
125 A - 1030 Denman Street Active Ingredient
Suite 100 is Hypericum perforatum
Vancouver, B.C. which is St. John's
V6G 2M6 Wort - 2/9/99
Canada 54Y--64
FEI# 3002597084 54Y--99
NOTE: CDER has determined that this product is being promoted as an
alternative to prescription drugs such as Fen-Phen and Imipramine and is
intended to treat obesity and depression and claims to correct the
"biochemical cause of weight loss". The product is described as an MAO
inhibitor. MAO inhibitors are a class of antidepressant drugs which can pose
health risks to patients if certain dietary restrictions are not observed
during therapy.
PRODUCT/PRODUCT CODE SOURCE
GAMMA-BUTYROLACTONE (GBL) 65V--51 (SEDATIVE) ALL
(SYNONYMS FOR GBL) 3/19/99
2(3H)-FURANONE DIHYDRO
BUTYROLACTONE
4-BUTYROLACTONE
DIHYDRO-2(3H)-FURANONE
4-BUTANOLIDE
2(3H)-FURANONE
DIHYDRO
TETRAHYDRO-2-FURANONE
BUTYROLACTONE
1,4-BUTANEDIOL/65V--52(SEDATIVE) ALL
(Note: FDA has identified GBL products labeled as: Renewtrient; Revivarant or
Revivarant G; Blue Nitro or Blue Niro Vitality; GH Revitalizer; PRO-G; Gamma G
and Remforce. This list should not be considered all-inclusive.)
GAMMA HYDROXYBUTYRATE (GHB)/65V--50 ALL
(SYNONYMS FOR GHB)
SODIUM GAMMAHYDROXYBUTYRATE (NaGHB)
POTASSIUM GAMMAHYDROXYBUTYRATE (KGHB)
GAMMA HYDROXYBUTRIC ACID
SODIUM OXYBATE
4-BUTANOLIDE
4-HYDROXYBUTYRIC ACID
4-OHB
ETHYL 4-ACEBUTANOATE
(Note: FDA has identified GHB products labeled as: Alcover; Gamma-OH;
Smatomax-PM; Somsanit; Anectamine; Natural Sleep 500, etc. This list should
not be considered all-inclusive.)
GBL and GHB also have many street names. Some of the most common are: G;
Liquid E or Liquid X; Georgia Home Boy; Great (Grievous) Bodily Harm; Liquid
Ecstacy; Scoop; Water.
GBL related products have been associated with reports of at least 55 adverse
health effects, including Death. When taken orally, GBL is converted in the
body to gamma hydroxybutyrate or GHB. GBL products are sold in liquid and
powder form.
GBL and GHB products are promoted with claims to build muscles, improve
physical performance, enhance sex, reduce stress and induce sleep. These
products are very potent unapproved drugs and powerful hypnotic substances
known to produce significant and potentially dangerous sedating effects.
District may detain the above products without physical examination from all
sources. FDA is aware these products are being offered for importation using
various non-drug claims such as: "wood softener" "bubble bath", etc. Further,
GBL is a known ingredient for commercial floor strippers. Never-the-less,
unless evidence is provided to the district that supports the product for non-
drug use, the product should not be considered for release. These products
are also inappropriate for release under FDA's Personal Importation Guidance.
For additional background information on GHB, please refer to import alert 66-
60. Questions regarding GBL/GHB can be directed to CDER/Office of Compliance,
HFD-310, Bradford Williams, 301-827-7364.
All Products Meditalent Enterprises Ltd. Taiwan
GPI = DR 87 Hsin Sheng N Road 8/4/99
GPI = VI Taipei, Taiwan 11/17/99
FEI# 1000441748
Meditech Enterprise Co. Ltd. Taiwan
PO Box 58388 8/4/99
Taipei, Taiwan 11/17/99
FEI# 1000132804
Firm Product/Product Code
(Note: products may be entering as skin care
cosmetics, therefore, we are including the
product code "53LC---" (Skin Care Preparations)
along with appropriate drug codes:
64L--28 (Fluocinonide)
64L--06 (Betamethasone dipropionate)
64L--99 (Glucocorticoids, n.e.c.)
Pramil Srl Regge Lemon Gel
Milan, Italy .05% Betamethasone dipropionate
FEI # 3002619397 64L--06/53LC
10/15/99
Topvate Cream
.05% Clobetasol Propionate
64L--99/53LC
Movate Cream Esapharma
.05% Clobetasol propionate
64L--99/53LC
Omic Gel Espharma
.025 g Fluocinonide
64L--28/53LC
Duwin Pharmaceutical and Chemical Co. Ltd.Regge Lemon Gel
38 Denton Street .05% Betamethasone dipropionate
Lagos, Nigeria 64L--06/53LC
FEI #3002558741
10/15/99 Topvate Cream
.05% Clobetasol Propionate
64L--99/53LC
Topsone Gel
.05% Betamethasone dipropionate
64L--06/53LC
Omic Gel Edkeen
.025% Fluocinonide
64L--28/53LC
Topsovate Cream Edkeen
.05% Clobetasone butyrate
64L--99/53LC
M Movate Industries, Inc. Movate Cream - M - 10/15/99
Milan, Italy .050 g Clobetason propionate
FEI #3002823220 64L--99/53LC
Tecmomed s.r.l. Dermo-Gel plus - Techmomed
viale san gimignano, 2 .075% Fluocinonide
Milan, Italy 64L--28/53LC
FEI #3002606542
10/15/99 Neoprosone-Gel Forte
.05% Betamethasone and
.1% Neomycin Sulphate
64L--06/53LC
Lemonvate Cream
.05% Clobetasol propionate
64L--99/53LC
N.P. Italiana srl Top-Gel with Special Sunscreen Agent
Napoli, Italy .025% Fluocinonide
FEI #3002823229 64L--28/53LC - 10/15/99
M.C.A. Medical and Chemical Agency Prosone Gel MCA
Via Parini, 13 .05% Betamethason dipropionate
S. Vittore Olona 64L--06/53LC
Milan, Italy 20028
FEI #1000167943 Top-Gel Plus MCA
10/15/99 .025 g Fluocinonide
64L--28/53LC
Mitchell International Pharmaceuticals LtdPro Beta-Zone
Unit 7 Kingston House Estate .05% Betamethasone dipropionate
Portsmout, Thames Ditton, UK 64L--06/53LC
FEI #1000480864
10/15/99 Beta-Vate
.05% Betamethasone dipropionate
64L--06/53LC
Mercury Top Gel
.05% Fluocinonide
64L--28/53LC
Topsone Gel
.05% Betamethasone dipropionate
64L--06/53LC
Omic Gel Edkeen
.025% Fluocinonide
64L--28/53LC
Topsovate Cream Edkeen
.05% Clobetasone butyrate
64L--99/53LC
Manufacturer:
Glaxo Smith Kline Uk Dermovate Cream
(a.k.a. Glaxo Wellcome Clobetasol propionate
Research & Development) 64L[][][][]
Greenford Road 10/15/99
Greenford, Middlesex, UK UB6 OHE
FEI #3000263379 Update name and product code
9/15/08
Shipper:
Salawu Enterprises Ltd.
10 Onikosi Steeet
Otta, Nigeria
FEI #3004526255
Laboratoires Mitchell Srl. Dermacare Gel
Paris, France .05% Fluocinonide
FEI #3002823274 64L--28/53LC
distributed by: 10/15/99
Sears Pharmaceuticals & Chemicals Ltd.
Nigeria
FEI #3002823282
Mitchell Cosmetics Srl Regge Lemon Gel
6 Bis Chemin Byron Case .05% Betamethasone dipropionate
Postale 59 64L--06/53LC
Geneva, Switzerland
FEI #3002582140 Omic Gel Plus
10/15/99 0.025 g Fluocinonide and Neomycin
Sulfate 0.05g
64L--28/53LC
Preventac Tablets, PremeTab, Formulex Canada, Inc. Canada
SomaTac, UriTab Caplets 5950 EST Chemin Cote-de-Liesse
60LBA05, 60LAA05 Ville Mont-Royal
54F- - 99, 54A- - 99 Quebec, Canada
5/19/00 FEI # 3002269313
PACKER/SHIPPER:
Ropack Inc.
10801 Mirabeau
Anjou, Quebec H1J 1T7
Canada
FEI # 3002674295
Products shipped by the following firms were found to contain the drug
glyburide, which is used to treat diabetes. These products are, being promoted
as dietary supplements & claim to contain only natural Chinese herbal
ingredients. They are available through mail order and can be purchased by
telephone or via the Internet. These products are being recalled under a Class
I recall as a health hazard.
All Products Heilongjiang Provincial Hechang China
GPI = DR Import and Export Co.Ltd.
GPI = VI Harbin, China
6/6/00 FEI# 3002799794
All Products Harbin Zhongshan Diabetes China
GPI = DR Research Institute
GPI = VI Harbin, China
6/6/00 FEI# 3003028087
Calidou Sun Lotion MFG. (per label) Canada
66P- -99 Prodemdis Enr.
6/8/00 St. Hubert, Quebec
Canada
FEI # 3003030473
MFG. (per shipper):
Laboratories Confab, Inc.
4355 Sir Wilfrid Laurier
St. Hubert, Quebec J3Y 3X3
FEI # 1000610344
Catalysis, S.I. Blue Cap Spray Spain
Zurbano 39 Blue Cap Cream 6/29/00
Madrid, Spain 28010 Blue Cap Shampoo
FEI# 3002989319
Product Codes:
Blue Cap Spray (100 ml, 3.33 fl oz): 62SAQ99, 61SAQ01, 61HBQ05,
53E[][]06, 53J[][]02, 53L[][]06
Blue Cap Cream (50 g, 1.6 oz): 62SAJ01, 53E[][]06, 53L[][]03,
53L[][]06
Blue Cap Shampoo (150 ml, 4.99 oz): 61HBL05, 63SAL01, 53E[][]06,
53L[][]06
Mifepristone All All
65J[][][][]/ 9/28/00
65D[][][][]
FDA has determined that unapproved versions of mifepristone manufactured
outside the U.S. are being promoted in this country for use to end pregnancy.
Due to the risks to the safety of the user in inadequately controlled
settings, mifepristone should be considered inappropriate for release under
the Personal Import Guidance. Districts encountering entries of mifepristone
should determine whether the importer of record for the article being entered
is Danco Laboratories, LLC, New York, New York (distributor of the U.S.
approved product) or whether the article is being entered under an IND that is
in effect. In such circumstances (when the article is being imported by the
distributor of the U.S. approved product or under an IND that is in effect),
the article is outside the scope of this guidance.
(Districts should contact CDER for verification of IND status.)
Source Product/Product Code Country
M.C.A. Top-Gel Super Italy
Medical and Chemical Agency 0,03 g Fluocinonide 2/12/01
Via Parini, 13 64L--28/53LC
S. Vittore Olona
Milan, Italy 20028
FEI #1000167943
All drug & dietary De-Sjamaan Netherlands
supplement products Hommelseweg 170 10/7/02
GPI - DR/IND - 54 Arnhem, Netherlands 6821
FEI #3003671336
All products ALPHA - Aleppo Pharmaceuticals Industries Syria
GPI = DR Baron Street, P.O. Box 517 11/21/02
GPI = VI Aleppo, Syria
FEI #3003659034
The following sources/products have met the criteria for detention without
physical examination. Shipments are likely to be encountered through express
mail or courier operations.
Certain drugs have special safety restrictions on how they are distributed.
These restrictions include distribution limited to facilities (such as
hospitals) or physicians with special training or expertise; or requiring
certain medical procedures (such as pregnancy or blood testing) if the drug
will be used. The following drugs are subject to a restricted distribution
program. Due to the serious health risks associated with the use of these
drugs with inadequate control, shipments of these drug are inappropriate for
release under the personal importation policy. For questions, Districts
should contact Ada Irizarry at the Center of Drug Evaluation and Research,
Division of Prescription Drug Compliance and Surveillance, HFD-330 at 301-594-
0101.
PRODUCT/PRODUCT CODES SOURCE COUNTRY
Isotretinoin All All
64X 11
12/06/02
Other names: Accutane, *** Accutane Roche 40, *** Retinoic Acid, 13-cis-,
Roaccutane, Isotrex, Accure, Amnesteem, Antibiotrex, Isohexal, Isotrex
Eritromicina, Isotrexin, Nimegen, Oratane, Roaccutan, *** Sotret, Claravis ***
*** Somatropin Recombinant All All
64R 23
2/19/04
Other names: Humatrope, Somatropin, Biosynthetic; Growth Hormone Recombinant
***
*** Abarelix All All
60V--99
2/19/04
Other names: Plenaxis ***
Firm My Drugs Canada
Address Jonathan Valicenti, PO Box 370, 1250 University St.
Montreal, Quebec, Canada H3B 3B0
FEI# 3004452174
^ ^
Firm Pharmacy RX Drugs Inc.
Address 9 Sundown Court, Thornhill, Ontario, Canada L4J 3V4
FEI# 3004452183
^ ^
Firm PharmAnabolics
Address Karznik Pretrova, Wroclaw, 5548 Poland
FEI# 3004452189
^ ^
Firm Pilot Mound Pharmacy
Address Darcey Mosquin, Box 89, Pilot Mound, MB Canada R0G 1P0
FEI# 3004452193
^ ^
Firm The U.P.P. Group
Address 74 Perry Drive, Sylvan Lake, Alberta, Canada T4S 1K4
FEI# 3004452206
^ ^
Firm TAME
Address 404-250 McDermont Avenue, Winnipeg, Manitobal, Canada, R3B 0S5
FEI# 3004452213
^ ^
Firm The Dispensary
Address NT Lusk, 25 Hipwood St, Brisbane, 4170 Australia
FEI# 3004452215
^ ^
Firm Liberty Lifestyle Pty Ltd.
Address Managing Director, PO Box 103 Concord West, Sydney, NSW 2138
Australia
FEI# 3004452224
^ ^
Firm DiscountMeds Online Corp.
Address PO Box 1005, Grand Anse, St. Georges, Grenada
FEI# 3004452230
^ ^
Firm 1drugstore-online.com
Address 429 Rochor Road, Startech Holding Limited 188452 Singapore
FEI# 3004452234
^ ^
Firm Punta Internacional de las Americas SA
Address Punta Punta, Costado Este del AutoBanco Nacional, Ave 10
San Jose, 11111 Costa Rica
FEI# 3004452237
^ ^
Firm DB Group (BHPHARMACY)
Address BLK 820, Yishun Street 81 #06-656, Singapore 760820
FEI# 3004452239
^ ^
Firm Border Pharmacy
Address 26 Abasolo y Reforma, C.P. 919020 Mexico
FEI# 3004452241
^ ^
Firm My Drugs Canada
Address PO Box 370,1250 University St., Montreal, Quebec, Canada H3B 3B0
FEI# 3004452242
^ ^
Firm Universal Needs SJ Inc.
Address PO Box 370, 1250 University St., Montreal, Quebec H3B 3B0 Canada
FEI# 3004452246
^ ^
Firm Fraser Valley Online
Address PO Box 435, Abbotsford, British Columbia, Canada V25 5Z5
FEI# 3004452248
^ ^
Firm MedsCorp
Address Courty Aunan, Blc. 5-6, Office 6b, Nurburger, 27850 Germany
FEI# 3004452249
^ ^
Firm Defining Presence Marketing Group Inc.
Address Universal Needs SJ Inc., PO Box 370, 1250 University Street
Montreal, Quebec, H3B 3B0 Canada
FEI# 3004452254
^ ^
Firm 111 Drugstore.com
Address Unknown Street Address, Singapore
FEI# 3004452260
^ ^
Firm Abas Pharmacy
Address Lakeside Computer Source, Box 136, Camp Morton, MB R0C 0M0, Canada
FEI# 3004452261
^ ^
Firm Adv-Care Pharmacy Inc.
Address Amr Bannis, 50 Heathcote Ave.,Toronto, Ontario, Canada M2L1Z1
FEI# 3004452262
^ ^
Firm Rx Resources Inc.
Address Box 11 Group 100 RR2, Lorette R0A 0Y0, Manitoba, Canada
FEI# 3004452266
^ ^
Firm Aptecha Inc.
Address Box 1158, Stonewall, Manitoba R0C 2Z0, Canada
FEI# 3004452268
^ ^
Firm LePharmacy Inc.
Address 7310 Mountain Sights Ave., Montreal, QC, Canada H4P 2A6
FEI# 3004452269
^ ^
^ ^
Firm TCE Group Inc.
Address Amr Bannis, 50 Heathcote Ave., Toronto, Ontario, Canada M2L 1Z1
FEI# 3004452278
^ ^
Firm Canada Med Express
Address 330 McCowan Road Suite 1508, Scarborough, Ontario,M1J 3N3 Canada
FEI# 3004452279
^ ^
Firm Arborg Pharmacy
Address 273 Main St, Box 640, Arborg, MB R0C 0A0, Canada
FEI# 3004452283
^ ^
Firm Canamerica Drugs
Address 12 Carina Cove, Winnipeg, MB, Canada R2V 4N8
FEI# 3004452158
^ ^
Firm Canadiansdrugstore.com
Address Martin Bean, 1609-200 Ronald St., Winnipeg, MB,
Canada R3J 3J3
FEI# 3004452159
^ ^
Firm Black Mountain IDA Pharmacy (1979) Ltd.
Address 11-590 Hwy. 33 W., Kelowna, B.C. Canada V1X 6A8
FEI# 3004452167
^ ^
^ ^
Firm Canada Rx Connection
Address 11 Ayr Blvd., Winnipeg, Manitoba, Canada R3P 0K4
FEI# 3004452169
^ ^
Firm Health 2000 Pharmacy
Address 105-6950 Nicholson Rd., North Delta, BC, Canada V4E 1Z7
FEI# 3004217327
^ ^
Firm MediMart Pharmacy
Address Paul Emmer, 1511-690 Kenaston Blvd. Winnipeg,
MB, Canada R3N 1Z3
FEI# 3004452182
^ ^
Firm Access Meds
Address 46 Parnlet, Newcastle, South Africa
FEI# 3004452185
^ ^
Firm Pharmacy International
Address 61 King George, Roseau, Dominica
FEI# 3004452192
^ ^
Firm Rx2world
Address c/- monarch holdings, PO Box 257, Port Vila, Vanuatu
FEI# 3004452194
^ ^
Firm E-pharmacy.net
Address World Pharmacy Supplies, c/-Suite 9, 14 Norton St,
Leichhardt 2040, NSW Australia
FEI# 3004452204
^ ^
Firm i-pharmacy
Address PO Box w66, Shop 3, 14-16 Military Rd. Watson's Bay NSW 2030
Austrailia
FEI# 3004452208
^ ^
Firm Planet Drugs Direct Ltd.
Address PO Box 33 893 Takapuna, North Shore City, New Zealand
FEI# 3004051223
^ ^
Firm Hometown Meds
Address Robert Watts, 43 Roslyn Rd, Winnipeg, MB, Canada R3L 0G1
FEI# 3004452214
^ ^
Firm Icanrx.com
Address Contact Media Group, 12840 16th Ave #203, White Rock, BC V4A 1N6
Canada
FEI# 3004452216
^ ^
Firm CANUSA Health Group
Address Doug Burton, 865 Brawley Road West, Ashburn, Ontario,
Canada L1M 1M5
FEI# 3004452226
^ ^
Firm Good Samaritan Rx
Address Dr Morgan Campbell Inc., 124 3185 King George Hwy,
Surrey, BC, Canada V4P 2J9
FEI# 3004452228
^ ^
Firm Pharmawest Pharmacy Ltd.
Address #69-15515-24 Avenue, Surrey, BC, Canada V4A 2J4
FEI# 3004452235
^ ^
Firm Direct Drugs
Address 1569 Orange Street, Winnipeg, Manitoba, Canada R3E 3S2
FEI# 3004452238
^ ^
Firm Pelikon Investments Limited
Address Peter Kraus, Mykinon 1, Nicosia, NO 1065, Cypress
FEI# 3004452302
^ ^
Firm Canadian Pharmacy
Address See Phuket, 12 De Castro Street, Tortola
British Virgin Islands, 12345
FEI# 3004452315
^ ^
Firm 1Meds
Address Steven King, 21 Marion St., Shorewood 7276, Taiwan
FEI# 3004452316
^ ^
Firm Canada Value Meds
Address Junodis Solutions, 47 Regent Ave., Hamilton, Ontario Canada
L9B 1R4
FEI# 3004452318
^ ^
Firm Americana Meds
Address Kelsie Mercer, 319 South River Road, Elora, Ontario, Canada
NOB 1SO
FEI# 3004452156
^ ^
Firm Online-Pharmacy
Address Online Pharmacy SA, Corrientes 1820, Buenos Aires,
Capital Federal 1108, Argentina
FEI# 3004452322
^ ^
Firm Discount Prescription Drugs Online
Address Liberty Lifestyle Pty Ltd, Barry West, P.O. Box 103 Concord West
Sydney, NSW 2138 Australia
FEI# 3004452329
^ ^
Foreign Websites Selling Accutane or Generic Isotretinoin
(1) Firm: Mac Pharma Network
Address: MAC Pharma Network
No.31, Block S
DHA
Lahore, Punjab 54792
Pakistan
FEI# 3005130603
^ ^
(2) Firm: Drugdelivery.ca
Address: Andrina Owens
Canadian Drug Delivery Inc.
11215 Jasper Ave Suite 601
Edmonton AB T5K 0L5 Canada
1-877-888-3562
FEI# 3005130862
^ ^
(3) Firm: 3a Pharmacy.com & 3amed
Address: Jakob Neubert
(WHITNEY-FERGUSON2 3 AMED.COM)
+45.28804290
Fax: +45.28804290
Aginavej 5
Copenhagen s, Copenhagen s 2300
Denmark
FEI# 3005130835
^
^
(4) Firm: Pharmanabolics.com
Address: Panacea International Ltd
Copthall, P.B. Box 2331
Roseau, Denmark
FEI# 3005130870
^ ^
(5) Firm: European-Pills.com
Address: Georgios Mitropoulos
(george_mit@hotmail.com)
European Pills
113 Aristomenous St.
Kalamata, None 24100
Greece +30-6944374425
FEI# 3005130887
^ ^
(6) Firm: Hallmark Pharmacy
Address: Hallmark Pharmacy
Organization Address
14 School Lane, Bengali Market
New Delhi
110001
DE
INDIA
FEI# 3005130889
^ ^
(7) Firm: Canada Prescriptions Plus
Address: Canada Prescriptions Plus
11420- 142 Street
Edmonton, Alberta T5M 1V1
Canada
Admin Contact: Cooper, Bill
wbc@canadaprescriptionsplus.com
FEI# 3005130899
^ ^
(8) Firm: Your-Online-Pharmacy.com
Address: Mikalai Markau
Polevaya 3A
Grodno, Belarus
FEI# 3005130944
^ ^
(9) Firm: MedsIndia
Address: Meds India, Ltd (MEDSINDIALTD3-DOM)
20 Macaw Avenue
Belmopan, Belmopan C.A.
Belize
FEI# 3005130954
^ ^
(10) Firm(s): Panacea-Pharmacy.com and/or
MedicaCenter
Address: Karznik
Petrova
Wroclaw, 5548
Poland
Admin Contact: Karznik, David
dkarznik@yahoo.com
FEI# 3004452189
^ ^
^ ^
Note: These two different firms are operating under the same firm address and
two different website locations.
(11) Firm(s): Night and Day Pharmacy.com and/or
Freedompharmacy.com and/or
Globalchemist.com
Address: Monarch Holdings (VTGREEPZWD)
2nd Floor, Windsor House
Lini Highway, P.B. Box 257
Port Vila, Fort Vila 00000
Vanuata
FEI# 3004452194
^ ^
^ ^
^ ^
Note: These three different firms are operating under the same firm address
and three different website locations.
(12) Firm: ValuePharmaceuticals.com
Address: Liberty Lifestyle Pty Ltd
Managing Director
PO Box 103 Concord West
Sydney, NSW 2138
Australia
FEI# 3004452329
^ ^
(13) Firm: Discount Meds
Address: DiscountMeds Online Corp.
(USAMEDICINE4-DOM)
P.O. Box 1005
Grand Anse, St. Georges
Grenada
FEI# 3004452230
^ ^
(14) Firm: OP Online Pharmacy.cc
Address: Online Pharmacy SA
Corrientes 1820
Buenos Aires, Capital Federal 1108
Argentina
FEI# 3004452322
^ ^
(15) Firm: The Dispensary.com
Address: NT Lusk
25 Hipwood St.
Brisbane, 4170
Australia
FEI# 3004452215
^ ^
Website Additions to Import Alert # 66-41 - Foreign Websites Selling
Clozaril or Humatrope
(1) Firm: Anabolics-Online
Address: Jarda Pokorny
(ANABOLICS-ONLINE-COM-DOM)
Libusina 37
Praha, 110 00
Czech Republic
FEI# 3005133122
^ ^
(2) Firm: Hormone Boutique
Address: CWP
PO Box 3149, Pasea Estate
Road Town,
Tortola,
British Virgin Isles BV 1000
FEI# 3005133124
^ ^
(3) Firm: Pharmacy-Network
Noprescriptiondrugs.com
Address: Azenith International LLC
Copthall PO Box 2331
Roseau
St. George, Dominica 00152
FEI# 3005133150
^ ^
^ ^
Note: These two different firms are operating under the same firm address and
two different website locations.
(4) Firm: HGH Human Growth Hormone
Address: Laura Vadillo
My Cancun Weddings
laura@my-cancun-weddings.com
Av. Sayil No. 24
Cancun, Quintana Roo 77500
Mexico
FEI# 3005133169
^ ^
(5) Firm: New Age Nutrition
Address: Discount Nutrition S.A.
Sayil
Cancun, Quintana Roo 77500
Mexico
Vadillo Laura director@ discount-human-growth-
hormone.com
St. George, Dominica 00152
FEI# 3005133172
^ ^
(6)Firm: Bestbuyinjectablehgh.com
Address: BIP Cancun S.A. de C.V. (FGNXPTCWTD)
Calle Azucenas SM.22 M.2, Lote 19
Cancun, ZZ 77500
Mexico
FEI# 3005133178
^ ^
(7) Firm: Pharmacy-online.com
Address: Barney Briton
#500, 400 Crowfoot Cresc. NW
Calagary, Alberta T3G 5H6
Canada
FEI# 3005133180
^ ^
(8) Firm: Imported Drugs
Address: Canam Shopping Services, Ltd
Suite #243 15-180 Central Road
Dunca, BC V9L-4X3
Canada
FEI# 3005133190
^ ^
(9) Firm: 3amed
Address: Jakob Neubert
(WHITNEY-FERGUSON2 3 AMED.COM)
+45.28804290
Fax: +45.28804290
Aginavej 5
Copenhagen s, Copenhagen s 2300
Denmark
FEI# 3005133196
^ ^
(10) Firm: 77canadapharmacy.com
Address: Pharmacy Network
Vancouver, BC V2V 1K4
Canada
FEI# 3005133203
^ ^
PRODUCT SOURCE COUNTRY
Sildenafil Citrate Wallace Service P/L Canada
Soft Tabs Clive Wallace
(Soft Tabs Viagra) 81 c Marine Parade
65P02 Seacliff, South Australia
5/27/05 Australia
FEI# 3004857162
^ ^
Sildenafil Citrate Medical Compounding Canada
Soft Tabs Software
(Soft Tabs Viagra) Box 421 Arnold Street
65P02 Richmond Hill
5/27/05 Ontario L4C 3R0
Canada
FEI# 3004857167
^
^
Fentanyl All All
60M 24
12/06/02
Other names: Actiq
PRODUCT/PRODUCT CODE SOURCE COUNTRY
Bosentan All All
60TCA99
12/06/02
Other names: Tracleer
Clozapine All All
65V 13
12/06/02
Other names: Clopine, Clopsine, Clozaril, Elcrit, Froidir, Lanolept, Leponex,
Zolapin
Dofetilide All All
63E 32
12/06/02
Other names: Tikosyn
Alosetron Hydrochloride All All
61T 30
12/06/02
Other names: Lotronex
Mifepristone All All
65J 38
12/06/02
Other names: Mifegyne, Mifeprex
Sodium Oxybate All All
60P--01
65V 50
12/06/02
Other names: Alcover, Anetamin, Gamma-OH, Somsanit, Xyrem
Trovafloxacin All All
61H 47
12/06/02
Other names: Trovan
Thalidomide All All
65V--40
12/06/02
Other names: Synovir, Thalomid
PRODUCT SOURCE
Ancom Tablets Shanghai Pharmaceutical Industry Corp. (mfg)
GPI=VI 27 Chungshan Road
GPI=DR Shanghai, China
2/12/03 FEI # 3003884699
China National Medicines & Health (shipper)
Products Import & Export Corp.
Shanghai Branch
27 Chungshan Road (E1)
Shanghai, China
FEI # 5534
Tourasia (internet promoter)
246 Sukhumvit Soi 16
Bangkok, Thailand 10110
FEI # 3003925496
Charisma Co., Ltd. (internet promoter)
248/1 Sukhumvit Soi 16
Bangkok, Thailand 10110
FEI # 3003925501
Source Product/Product Code Country
(manufacturer) "Busto-Lift" capsules Italy
Italiani Selex and cream for growth 04/23/03
20063 Cassina de Pecchi enlargement of the
Milano, Italy Female bust
FEI # 3003901090 53LC-99
66VA-99
(shipper) 66VB-99
Luoice Marketing Enterprise
No. 7 Off Jalan Bukit Bintang
Luala Lumpur, Malaysia
FEI # 3003901091
(manufacturer) "Recovery Biostructural Canada
Biomedica Laboratories, Inc. Medicines" for relief of 4/29/03
"No Street Address" Chronic pain and
Vancouver, British Columbia, inflammation
Canada
FEI # 3003807448 54FCR99
(Shipper)
The Nutraceutical Medicine Co.
Unit #2, 3006 Boys Road
Duncan, British Columbia, Canada V9L 6W4
FEI # 3003056414
Chemon Inc. "Joint by Joint" Korea, Republic of
4645 Chung-Ri Supplement 5/5/03
Kusung-Up, Yougin-Si GPI - DR/VI
Kyungki-Do, Korea
FEI# 3003952905
Product Source: Country:
Sildenafil citrate Generic Viagra Bz Belize
(generic) 5870 Manatee Drive
65P02 Button Wood Bay, Belize
5/23/03 FEI# 3003868410
^
^
All drugs Mr. Vikan Thailand
GPI-DR Carrefour Rama 4 Road
GPI-VI MBE Suite 019
5/23/03 Bangkok, 10110, Thailand
FEI# 3003885661
^
^
Agrumax Bioxem, Inc. Canada
54AGL90 1421 Nobel
8/19/03 Sainte-Julie
Quebec, Canada
FEI# 3003756848
Face Cream Diane de Beaute All
53L[][][][]/64X[][][][] PO Box 11-7599
9/5/03 Beirut, Lebanon
FEI# 3003914273
Charantia Ampalaya Herbcare Corp. Philippines
Food Supplement Herbcare Center, PDC Compound
54E[][]99 - Tea form Pilar Village, Las Pinas City,
54F[][]99 - Capsule form Philippines
FEI# 3003865977
and
Herbcare Corp. Philippines
Box 163
Las Pinas City,
Philippines
FEI# 3003659682
Herbal Medicines including Akita Herbal Products Philippines
Gluco-Norm Gold, Corner Volga and Zambensi Streets
Banabooster, Riverside Subdivision Friendship
Cancers Protocol Angeles City, Philippines
54Y- - - FEI #3003977207
66V- - -
11/17/03
Eleotin (and all products Eastwood Bio-Medical Canada
from this firm making Research Inc. any drug claims)\
#1130-4871 Shell Road
GPI = DR
Richmond, B.C. V6X 3Z6
GPI = VI CANADA
61P[][]99 FEI #3001619750
54F[][]99
12/1/03
The product label indicates Eleotin is a supplement, but refers customers to
the firm's website www.eastwoodcos.com which claims the product can be used to
treat diabetes. The product can also be purchased from the firm's website.
The website claims Eleotin restores the body's own ability to control blood
glucose levels and results in long-term molecular level changes to assist the
body to recover glucose normalcy.
According to the firm's website, Eastwood Bio-Medical Research Inc. is engaged
in the development and commercialization of safe and effective treatment for
non-insulin dependent diabetes mellitus and cancer.
Careseng #1 Pegasus Pharmaceuticals Group Inc. Canada
(Capsules & Liquids) 3331 No. 3 Road
66V -- 99 Richmond, British Columbia
1/13/04 Canada
FEI #3004153848
Careseng #2
66V- -99 Dba
3/1/04
Pegasus Natural Supplements, Inc.
Unknown
Richmond, Canada
FEI #3003817323
Pegasus Pharmaceuticals, Inc.
#156 11786 River Rd
Richmond, Canada
FEI #3003114241
Pegasus Pharmaceut
156 11786 River Road
Richmond, Canada
FEI #3003659429
PRODUCT SOURCE COUNTRY
All Products American Style Products India
2/6/04 BHikaji Cam PL
New Delhi, IN
FEI: 3004413333
The agency received information about an overseas internet site se
lling
counterfeit contraceptive patches that contain no active ingredien
ts. The
counterfeit contraceptive patches were promoted as Ortho Evra tran
sdermal
patches, Ortho Evra transdermal patches, a Johnson and Johnson's
Ortho-McNeil
Pharmaceutical, Inc. product.. This internet site's domain name
is
www.rxpharmacy.ws .
Ukrain Nowicky Pharma Austria
2/6/04 Margaretenstrasse 7
Vienna, a-1040
FEI: 3000960791
UKRAIN is an injectable promoted as an anticancer drug. Districts
encountering shipments of this product should contact DIOP using the ORA HQ
DIOP EMPLOYEES e-mail for guidance.
PRODUCT/PRODUCT CODE SOURCE COUNTRY
All Skin Bleaching and Catherine Abbaa Nigeria
Lightening Lotions, 98 Badagry Exp. Way
Creams, Soaps and Lagos, Nigeria
Serum FEI# 3003407077
66[][][][]
53[][]-[][]
3/9/04
Note: products may be entering as skin care cosmetics, therefore, we have
included the product code "53[][]-[][]" along with the appropriate drug code.
PRODUCT/PRODUCT CODE SOURCE COUNTRY
Humatrope ALL ALL
64R[][]23
3/26/04
Other names: Somatropin, biosynthetic; Growth Hormone Recombinan
Plenaxis ALL ALL
60V[][]99
3/26/04
Other names: Abarelix
PRODUCT SOURCE COUNTRY
Plaquex All All
3/26/04
A product used for chelation therapy is represented to be useful in a number
of therapeutic conditions. It is called Plaquex. The product comes into the
country from the Bahamas using the personal importation policy on the "front"
end, however a recently detained package eclared the contents to be a
nutritional supplement. The company involved in this is called Jeunomed
International and it has a Key Biscayne address. Product administration is by
IV and requires refrigeration. One 50ml vial is said to contain 2500ml
essential Phospholipids as 70% Phosphatidylcholine, 1250mg Deoxycholic acid,
10mg Vitamin E, 10mg Nicotinic acid, 10mg Adenosine triphosphate, 450mg Benzyl
alchohol and 120mg Ethanol. Plaquex, is an injectable drug product, and as
such, it poses a significant health risk and it is being promoted in the U.S.
through the internet ; e.g. http://www.plaquex.ch/.
PRODUCT SOURCE COUNTRY
V-1, V-4 Magnesium Jirashataporn Co., Ltd. Thailand
Dietary Supplements 72/2-3 Moo 10 Sukumvit Rd.
GPI=DR Chachoengsao, Thailand
54Y- -99 FEI# 3004375809
54B- -08
4/15/04 Immunitor Manufacturer Co., Ltd. Thailand
71 Moo 5,Bangpakong Industrial Park
Chachoengsao, Thailand 24130
FEI# 3004375808
Avicenna Pharma brand A.M. Herbs(M) SDN BHD Malaysia
Dietary supplements: 2-4 Jalan 3/114,
Cholestmed Kuchai Business Center
Glucosure 58200 Kuala Lumpur
Gastro Balance Malaysia
Renalife FEI# 3004686954
Livtone
Respire
Product Codes: 54Y--99 54F--99
9/1/04
PRODUCT SOURCES COUNTRY
Sildenafil Citrate Vee Excel Drugs & India
Tablets Pharmaceuticals (P) Ltd
65P02 G-16, 3rd Floor
9/16/04 Preet Vihar, Vikas Marg
Delhi, India
FEI# 3004062123
Vee Excel (V Excel International)
2, Veer Sawarkar Block
Triveni Complex
Madhuban Road, Shakar Pur
Delhi, India
FEI# 3003945550
Vee Excel Drugs & Pharmaceutical
R-23-B, 1/F, Rita Block
Delhi, India
FEI# 3004062373
PRODUCT SOURCES COUNTRY
Wings Heartdrop Formula Wings International CANADA
Herbal Tinture Marketing Ltd.
54F[][]99 6595 Herry Road.
9/30/04 Vernon, BC
Canada
FEI #3004497001
PRODUCT SOURCES COUNTRY
"Actra-RX" Shenyang Changgong Yibao All
Other names: "Yilishen" Alcohol Co. Ltd. Under the supervision of
54- - - - Shenyand Medicline Research on
65P- - -02 Biologic Resource
(Contains prescription 126 Changbai Street, Dongling District
strength Shengyang, Liaoning, China
sildenafil by FDA analysis) FEI: 3003791634
11/10/04
PRODUCT SOURCE COUNTRY
All IVFMeds Gibraltar
GPI=DR Suite 5, Ellicott House
2/16/05 1/3 Town Range
Gibraltar
(no FEI)
All Bowling Chemist Ltd. United Kingdom
GPI=DR 7 Wardour Street
2/16/05 London, WID 6PE
United Kingdom
FEI# 1000474709
Background: Based on accompanying documents, the product appears to be a
new drug without an approved application. An internet-based pharmacy,
IVFMeds, is reportedly filling orders using certain unapproved foreign
versions of Serono fertility products through another UK-based pharmacy called
Bowling Chemists Ltd. In addition, after reviewing the firm's website
www.ivfmeds.com, it appears that IVFMeds also promotes and offers for sale
into the U.S. foreign versions of various other unapproved drug products.
PRODUCT/CODE SOURCE COUNTRY
Anthelios XL Cr�me La Roche-Posay France
Ultra Protection UVA 60+SPF Labatoire Pharmaceutique
Anthelios XL Lait 86270 La Roche Posay, France
Ultra Protection UVA 60+SPF FEI# 3003818446
Antherpos Protection UVA
SPF 50
Anthelios XL Fluid Extreme
Ultra Protection LSF 60
66P 99
65L 99
53L 99
3/2/05
Background: Based on accompanying documents, the above specified La-Roche-
Posay sunscreen products appear to be new drugs without an approved
application (NDA). These products contain ingredients that are not permitted
in the final rule for Sunscreen Drug Products for Over-The-Counter Human use
[21 CFR Part 352]. 505(a) charge.
PRODUCT SOURCE COUNTRY
Bryson Primer # 1 Bryson Garden Remedies Canada
Cleansing Herbal Formula 1695 Franklin Street
54FCL99 Vancouver, Canada
3/21/05 FEI# 3003274380
SAFI, Blood Purifier Hamdard (WAKF) Laboratories India
54F[][][][] Ghaziabad, India
3/21/05 FEI# 3004659877
2000027663
Beijing Kowloon Pharmaceutical Stamax Sexual Stimulant China
Factory Dietary Supplement
No 1200 Diyang Bldg. 66S[][]51
Beijing, China
FEI# 3003880203
5/16/05
PRODUCT SOURCE COUNTRY
Powder Enlarge Patch Cybermed Industries Canada
80L[][]DQ 204-1010 View Street
54F[][]99 Victoria, BC, Canada V8V4V3
66V[][]99 FEI# 3003657059
5/26/05
Background: Power Enlarge Patch is offered for sale on this firm's Internet
site at www.enlargepatch.com. This product is promoted as a transdermal patch
that infuses its ingredients directly into the bloodstream, bypassing the
digestive system. Based on its intended uses, Power Enlarge Patch is a drug.
As labeled and formulated, this drug is not generally recognized as safe and
effective by experts, and is a new drug marketed without an approved new drug
application. Furthermore, because this product is a transdermal drug, the
method of administration or application suggested in the labeling causes it to
be a new drug. See 21 CFR 310.3(h)(5). Per CDER the appropriate charge is
505(a).
PRODUCT SOURCE COUNTRY
ESNATRI brand ALL ALL
natural triple
estrogen moisturizing
cream
53B----
53L----
64G----
6/2/05
Based on accompanying documents, Esnatri brand estrogen moisturizing
cream appears to be a new drug without an approved application NDA).
^ ^
Product SOURCE COUNTRY
All topical "Black Salve" ALL ALL
Products
66V[][]99
54E[][]37
54E[][]99
54F[][]99
54Y[][]99
(Black Salve is also known by
the following other names: Cansema Black
Topical Salve, Cansema Deep Tissue,
Cansema w/Lugol's Iodine (topical),
Cansema for Cats, Dogs, and Horses,
Cansema Tonic I, Cansema Tonic II,
Cansema Tonic III, Cansema Capsules,
Cansema Suppositories, Bloodroot Paste,
C-Herb Paste, CAN-X, Cancerx, H3O, Healing
Formula)
6/2/05
Background/Reason for Alert: Black salve, also known by the names cited
above, has been advertised for use in the cure, mitigation, treatment or
prevention of cancer. In addition, various websites promote black salve
products for use in the treatment and cure of cancer, tumors, herpes, venereal
diseases, diabetes, lupus, and internal malignancies. Based on its intended
uses, this product is a drug. Further, CDER is not aware of any substantial
scientific evidence that demonstrates that this product is generally
recognized as safe and effective for its labeled uses. Districts may detain
without physical examination any product named above, and refuse entry to any
black salve product that is labeled or is accompanied by labeling, with claims
that it is intended to diagnose, cure, mitigate, treat or prevent a disease.
Product/code: Source: Country:
DIATECH 2000 Pharmatech 2000 Canada
Food Supplement 16508 100 Street
54F[][]99 Edmonton, AB, Canada
7/25/05 FEI# 3004024126
PRODUCT SOURCE COUNTRY
Serrapeptase Enerex Botanicals Ltd. Canada
(Serratia Peptidase Enzyme) 8531 Eastlake Drive
66V[][]99 Burnaby,
54[][][]99 British Columbia V5A 4T7
8/23/05 Canada
FEI# 3003787333
Note: product may be entering as a dietary supplement, therefore, we have
included the product code "54[][]99" along with the appropriate drug code.
The product's accompanying literature and indicates Serrapeptase(Serratia
Peptidase Enzyme), among other claims, is used to treat arterial blockage in
coronary patients" and the product has anti-inflammatory and pain blocking
benefits. The firm's website, ^ ^ makes similar claims.
In 1982, Woodward's Gripe Water was promoted for infants including newborns
and older children over 12 months of age and labeled for gripes, acidity,
flatulency, a quick and gentle way of relieving baby's hiccups, minor tummy
upsets and teething. The article contains, among other things, dill oil or
dill water, sodium bicarbonate, and 3.67 4.69% alcohol. Gripe water has been
used in various foreign countries for many years. However, in the United
States it is not generally recognized as safe and effective for its intended
uses, based on its formula and labeling, and therefore, is considered a new
drug which cannot be marketed without an approved New Drug Application. In
addition the Center for Drugs Evaluation and Research (CDER) has safety
concerns regarding the dill oil or dill water ingredients. A recent OASIS
data search indicates that there continue to be importations of gripe water
into the U.S. at various ports of entry. Districts should Detain Without
Physical Examination shipments labeled as gripe water or other types of water
aqueous products (i.e., dill water, dill oil) which might be labeled with drug
claims.
Firm Name and Address: Product/Product Code:
All Gripe Water
8/25/05 66V[][]99
54F[][]99
NOTE: This product was previously subject to Detention Without Physical
Examination under Import Alert #66-09. Effective as of the issuance of these
notification shipments of gripe water should be detained per Import Alert #66-
41, "Unapproved New Drugs Promoted in the U.S."
FIRM NAME AND ADDRESS PRODUCT/PRODUCT CODE
Inter Medical Lab Bangkok Slim Weight Loss Program
AKA Inter Medical Clinic GPI=DR/54-----
24-16 Phahonyothin Rd I Inter Bangkok Clinic Weight
Loss Bangkok, Thailand GPI=DR/54-----
9/16/05 FEI# 3003141248
Manufacturer
Gynostemma Pentaphylla Weimin Medicine Manufactory China
And Evening Primrose Pills Unknown Street Address
54F[][][] Beijing
54H[][][] FEI# 3005271572
54Y[][][]
GPI=DR Shipper
10/28/05 Yung Sing Enterprises Ltd. Canada
279 E. Pender Street
Richmond
British Columbia
FEI# 3002950572
Herbal Life (or Herbal Life and ALL Products Canada
Essence Co.) GPI = DR
2416 Main Street, Unit 132 IND - 54
Vancouver, Canada (BC)
FEI# 3004136252
11/25/05
[Note: This firm is connected to the website ^ ^
that is promoting various products for use as street drug alternatives. The
agency considers any product that is promoted as a street drug alternative to
be an unapproved new drug and a misbranded drug in violation of Sections 505
and 502 of the FFDCA.]
Bioxira Health Technologies, Bioxira Skin Cream Impregnated Cloth
S.A. de C.V. Bioxira PreventAge 1.0
Callejon Zaragoza No. 1 Bioxira Defining 1.0
Cuajimalpa, Distrito Federal
Mexico
FEI# 3005011306
^ ^
12/7/05
PRODUCT SOURCE COUNTRY
Emagrece Sim Dietary Fitoterapicos (Fytoterapicos) All
Supplement (all Levels) Rua Estrela Dione 340
GPI-DR/54[][][][][] Riacho das Pedras
12/23/05 Contagem, Brazil
FEI# 3005061819
Emagrece Sim Dietary Phytotherm Sim All
Supplement (all Levels) Rua Estrela Dione 300
GPI-DR/54[][][][][] Contagem, Brazil
12/23/05 FEI# 3005289514
Herbathin Dietary Supplement Fitoterapicos (Fytoterapicos) All
(all Levels) Rua Estrela Dione 340
GPI-DR/54[][][][][] Riacho das Pedras
12/23/05 Contagem, Brazil
FEI# 3005061819
Herbathin Dietary Supplement Phytotherm Sim All
(all Levels) Rua Estrela Dione 300
GPI-DR/54[][][][][] Contagem, Brazil
12/23/05 FEI# 3005289514
Laboratorio Urena Sa Te Diossana
Via Argentina EDF Balmoral 54Y[][]99
Panama City, Panama 31K[][]99
FEI# 3005274240 54E[][]99
1/5/06
NOTE: The label of the herbal product includes the website:
^ ^ This website makes direct reference to
treatments for cancer cures as well as treatments for AIDS and diabetes.
Additionally, a letter that accompanies the imported product states in Spanish
that this product has been used to treat patients with cancer, leukemia, and
HIV positive obtaining good results even on those patients with terminal
conditions. We are not aware of any substantial scientific evidence that
establishes that this product is generally recognized as safe and effective
for its intended use. This product is not the subject of an approved new or
abbreviated new drug application.
Liver Cleanse Innercleanse 2000 Inc. Canada
Lung Cleanse AKA Herbal Care Direct, Inc.
Kidney Cleanse 2319 Fairview Street
Arterial Cleanse Unit 608
Anti-Para Parasite Cleanse Burlington, Ontario
54I[][]99 54B[][]99 L7R2E3
54E[][]99 54C[][]99 FEI# 3002671576
54F[][]99 54Y[][]99 FEI# 3004011959
66V[][]99
8/11/06
Note: product may be entering as a dietary supplement, therefore, we have
included the product code "54[][]99" along with the appropriate drug code.
The product labeling for the above products do not make any drug claims
however, the firm's website that provides drug related information on the
products ^ ^ and their ordering website that also
provides drug related information ^ ^ makes
claims such as curing kidney infections.
Nature Products Revivo (Chinese Herb Mix)
Mekong Hill Garden 62V[ ][ ]99
Jinghong, Yunnan 54Y[ ][ ]99
China 2/1/06
FEI# 3005550994
NOTE: This product is promoted to treat AIDS/HIV infection and other viral
diseases on the firm's website ^ ^.
Beijing Kowloon Pharmaceutical 4EVERON SEXUAL STIMULANT
Factory, Rm: 105, No. 3 TABLET
Tianzhuzhongjie Shunyi District (declared as L-arginine
Beijing, China dietary supplement)
FEI# 3003880203 54C[][]02, 54F[][]29
54Y[][]99, 65P[][]02
3/29/06
^
^
Industrias Quimicas Kemed S De Cv Phenocane Dietary Supplement
Callejon De Las Moflas 11901 62G[][]99
Tijuana, BC 54F[][]99
Mexico 54Y[][]99
FEI# 3004268316 4/6/06
PRODUCT SOURCE COUNTRY
"Marine Phytoplankton" Unique Seafarm Canada
Core Marine Phytoplankton 3145 Headland Rd
Capsules & Liquid Nanaimo
66V--99 Canada
5/3/06 V9X 1N8
FEI# 3005095075
Product/Code: Source: Country:
PEB One and PEB Two Capsules Michelle Gleneuine Brazil
(Brand Renutryent) Dietary Av. Canal Marapendi
Supplement No. 4100/1105, BL1
66V[][]99 Rio de Janiero, Brazil
5/4/06 FEI# 3005524067
FDA has determined that this product contains the undeclared prescript
ion
drug ingredients Fenproporex HCl and Chlordiazepoxide HCl. Both are Sc
hedule
IV Drugs. Fenproporex hydrochloride has been used as an anorectic in t
he
treatment of obesity although the use of stimulants in this way is no l
onger
recommended. Chlordiazepoxide is used in the short-term treatment of a
nxiety
disorders, insomnia, muscle spasm, alcohol withdrawal syndrome, and for
anesthetic premedication before surgery. The product is labeled for th
e
treatment of weight reduction by increasing the metabolism, controlling
anxiety, and inhibiting excessive appetite. Based on its intended uses
, this
product is a drug. There is no substantial scientific evidence that thi
s
product is generally recognized as safe and effective for the condition
s
recommended or suggested in its labeling.
Shu Li Foot Pouches Ion Farms Co Korea, (South)
80KGX 2f Donggyoung Bd
5/12/06 Incheon
Korea, (South)
FEI# 3005463878
PRODUCT SOURCE COUNTRY
Salusil/61H[][]99 Frigor & Chemicals Ltd. Israe
l
Tetrasil/61H[][]99 P.O. Box 12053 Industrial Area
5/16/06 Hefer, Israel 38800
FEI #: 3003887525
Psorcure Oil Dr. Shelender Dhawan (Manufacturer) India (IN)
Psorcure Ointment 1759 Sector 16, Faridabad
Psorcare Capsules Haryana
Psorclean Tablets India
Psorcalm Capsules FEI #3005619744
Immunopsor Drops
5/25/06
Psorcure Oil ECom Consultant (Shipper/Distributor) Canada (CA
)
Psorcure Ointment 4 Cobbler Street
Psorcare Capsules Brampton, Ontario L6X 4T4
Psorclean Tablets Canada
Psorcalm Capsules FEI # 2000011553
Immunopsor Drops WWW.Clinicpsoriasis.com
5/25/06 WWW.Psorcure.com
Manufacturer
Opto-Pharm Pte Ltd. "Ortho-Eyes" Lubricant Eye Dro
ps
13 Tuas Avenue 12 (Labeled as a dietary sup
plement)
Singapore 639035 66V[][]99
FEI# 3005320466 54Y[][]99
6/1/06
Shipper
AOR Inc./
Advanced Orthomolecular Research
Bay 9, 4101 19 Street N.E.
Calgary, Alberta T2E 6X8
Canada
FEI# 3004288965
^
^
Bio-Gulf Sdn Bhd Libidus
24-2 Medan Setia 2 65P[][]02
Plaza Damansara 54Y[][]99
50490 Kuala Lumpur 54F[][]99
Malaysia
FEI# 3004792803
3005314803
NOTE: "Libidus" is promoted on the Internet websites ^
<<< and ^^ and >>> www.biogulf.com <<< as an herbal, male, sexual stimu
lant and has
been imported into the U.S. as a dietary supplement. Analysis provided
by
CDER's Division of Pharmaceutical Analysis, HFD-920, found that the cap
sules
contain the undeclared chemical "acetildenafil," an analog of sildenafi
l.
Sildenafil citrate is the active ingredient in Viagra a product manufac
tured
by Pfizer for the treatment of erectile dysfunction. "Acetildenafil" i
s not
declared as one of the ingredients on the Libidus' product's label and
the
pharmacology of this new drug is unknown.
"Green Sun" Antiviral Gel Natropractica (Website Registrant)
54Y[][]99 Christoper Scipio (natropractica@aol.com
)
08/25/06 1950 West Broadway
Vancouver, BC V6J 5C2, Canada
Website: www.natropractica.com
FEI #3005860590
"Green Sun" is promoted on Natropactica's website, www.natropractica.co
m, for
use as an "Yeffective barrier which inhibits the ability of HPV, Herpes
and
other STIs (Sexually Transmitted Infections) from replicating on the su
rface
\of the skin and inhibits their ability to adhere to the skin. We deve
loped
our own anti-viral gel lube with Carrageenan and other substances we we
re
\already working with in the protocol and developed out own formula." A
lso,
\the following metatag key words are connected with this website: "anti
-viral
gel;" "genital herpes;" "Genital Herpes Symptoms;" "varicella zoster;"
shingles;" "sexually transmitted diseases;" " STD;" "AIDS;" "HIV;" "inc
urable
diseases;" etc.
Based on its intended uses this product is a drug. Further, we are not
aware
of any substantial scientific evidence that this product is generally
recognized as safe and effective for the conditions recommended or sugg
ested
in its labeling.
Sweet Cures Waterfall D-Mannose Any Sweet Cures Unite
d Kingdom
36A[][]99 101 Foxwood Lane
York, YO24 3LQ
United Kingdom
FEI# 3005724802
09/27/06
Pro Sero Co., Ltd "Pro Sero Plaster"
7F., No. 122, Section 1, pain relieving patch
Ho-ping West Road 60L[][][][]
Taipei, Taiwan, Republic Of China 79K[][]GX, 89M[][]LX
FEI# 3003179061 10/27/06
Swiss Medica, Inc Essential Oil Neutralizer Canad
a
53 Yonge Street, 3rd Floor 024 Fibromyalgia
Toronto GPI = DR
Canada 11/1/06
FEI# 3004932367
^ ^
SOURCE PRODUCT COUNTRY
Dragonedge Resources Revitapatch Japan
1207 Jasmine Towers (All Natural Detox) 11/13/06
Selangor Foot Patch
Malaysia GPI=DR
FEI# 3005748500 GPI=DE
GPI=CO
Revitapatch is manufactured in Japan and is known to be distributed thr
ough
Malaysia. The product is a combination product as defined under 21 CFR
3.2(e)(1)(the pad is the device portion and the ingredients absorbed in
to the
pad make up the drug portion). The product's labeling declares Revitap
atch is
a detoxifier; and as promoted on the product's website, declares Revita
patch
improves blood circulation, increases the metabolism, activates red blo
od
\cells, enhances the quality of sleep and aids in the release of toxins
through the skin.
^
^
All Products Catalysis, S.L. Spain
GPI=DR, GPI=VI Macarena 14
12/11/06 Madrid, Spain 28016
FEI # 3002989319
http://www.catalysisusa.net
Coffee S.A. Wilson
Canada
Coffee with Enema Kit 2891 Regional Rd. #2
0 Unit #2
66V[][]99 Bowmanville, Ontario
12/ /06 Canada L1C 3K6
FEI# 3005507009
PRODUCT SOURCE COUNTRY
Ayurvedic Fair and Lovely Cream Hindustan Lever Ltd. India
53L[][]03 Dag No 21 of 122 F.s.grant
11/3/06 Mouza-tingra
Doomdooma Industrial Estate, Off Nh-37
Ayurvedic Fairness Cream Mumbai, India
53L[][]03 FEI# 3004356927
11/3/06
Fairness Cream for Men Herbo Foundation, Shed 24 India
(Fair and Handsome) Industrial Estate
53L[][]03 Guwahati, India
11/3/06 FEI# 3005501533
PRODUCT SOURCE COUNTRY
Ranitone/Rani Tonic Rani Drug House India
GPI=DR Nellayi
54F[][][] 53B[][][] Thrissur District
54Y[][][] 53E[][][] Kerala, India
31K[][][] 53F[][][] FEI# 3005734324
31L[][][] 53L[][][] ^ ^
31P[][][] 53J[][][]
1/25/07
PRODUCT/PRODUCT CODE SOURCE COUNTRY
Isotretinoin All All
64X [] [] 11 2/8/07
Foreign Websites Selling Isotretinoin
Sharpmeds.com
Jose Carlos domain @ sharpmeds.com
Apartado Postal 10-65666
Mexico City, null 425369
Mexico
phone: 52.5542369532
FEI# 3006084927
^ ^
Gold Shield Corporation
23-845 Dakota Street-300
Winnipeg, Manitoba R2M 5M3
Canada
^ ^
^ ^<
FEI# 3006076714
VrDrug.com
451 Ladprow Rd
Wangtonglang, Wangtonglang
Bangkok, Bangkok10210
Thailand
^ ^<
FEI # 3006076729
Note: The above firm appears to market clozaril (clozapine) as well as
isotretinoin.
Medisave.ca
Medisave
1364 Cliveden Ave.
Delta, British Columbia,
Canada V3M 6K2
^ ^
FEI# 3005359913
Heibert Net Inc
Al Wong
8181, 120 A Street, Suite #2
Surrey BC V3W 3P2
Canada
^ ^
^ ^
^ ^
FEI# 3006093160
AnabolicShop
DG (Damian Garel)
damiangarel@gmx.de
Lofgister 34
Bjorntal, 5689
Sweden
69845564
^ ^
FEI# 3006078870
Note: The above firm appears to market various anabolic steroids as well as
isotretinoin on its website.
Rx-Pharmacy.cc
Pharm Export
Hornweg 18
Amsterdam, AR 1045
Netherlands
^ ^
FEI# 3006078881
Note: The above site appears to be selling accutane online and includes
airmail shipping.
bestonlineforeignpharmacies.com
ExpertInfo, Inc.
Jose Luis Soto
PO Box 2411-0834
Panama City,
Panama
^ ^
FEI# 3006078947
Note: The above site appears to be a buyer's group.
North Pharmacy Inc
110-165 Kimta Road
Victoria V9A 7T1
Canada
^ ^<
FEI# 3006078952
CanPharm
P.O. Box #88614
Surrey, BC V3W 2P2
Canada
^ ^<
FEI# 3006080166
Newton Pharmacy
1004-7445 132 St
Surrey, BC, Canada
V3W 1J8
^ ^
^ ^
^ ^<
FEI# 3005349015
Note: The above (3) firms have the same URL website.
Guillermo Rivera
Chivilcoy 4820
Capital Federal, Buenos Aires 1419
Argentina
^ ^
FEI# 3006080192
Solaris Worldwide
1364 Cliveden Ave.
Delta, BC V3M 6K2
Canada
^ ^
FEI# 3006080199
CanadaDrugsOnline.com
1364 Cliveden Ave
Delta, British Columbia
Canada V3M 6K2
^ ^
FEI# 3005335274
Planet Systems, Inc.
John Variss
58 Shirley St., 1st Floor PO Box 88 15670
Nassau, Bahamas
^ ^
FEI# 3006084943
Tangny Enterprises, Inc.
Edificio Banco Aliado
Calle Ricardo Arias, Piso No. 15
Apartado 6443
Panama 5, R. de Panama
^ ^
FEI# 3006084950
Indianmeds4u.com
235/a,
Mumbai 11
INDIA
^ ^
FEI# 3006084980
Indian Meds 4u
B-311, Place, Gaulind Road
Patna(city)
Bihar(province)
INDIA
^ ^
FEI# 3006084999
AAA Webmanagement AG
Aegeristrasse 4
Zug, Kantone Zug 6301
Switzerland
^ ^
FEI# 3006086033
MSAP
144 Richmond Hill Rd
Sumner
Christchurch, Canterbury 8008
U.K.
^ ^
FEI# 3006086041
Onlinepharmashop.com
Cigdem Aksoy
Burj el Arab
King suite
Dubai 6676543
United Arab Emirates
^ ^
FEI# 3006086047
Medesis Pharmacy Inc.
Hooman Tabarsi
7505 Victoria Drive
Vancouver, British Columbia V5P 3Z6
CANADA
^ ^
FEI# 3004619313
Canadacure
7505 Victoria Drive
Vancouver, BC V5P 3Z6
CANADA
^ ^
FEI# 3005917828
Abbott Renuka Pharmacy Ltd.
420 Abbott St.
Vancouver, British Columbia V6B2L1
CANADA
^ ^
FEI# 3003919300
OnlineCanadaMeds
#400-601 6th Street
New Westminster, British Columbia
V3L3C1, Canada
^ ^
FEI# 3006086393
Natsuko Enterprises
362-10-1104 Kamiokuma
Kasuya-machi
Kasuya-Gun, Fukuoka 811-2301
Japan
^ ^
FEI# 3006086773
Farmacia Centrale
Farmamondo
Via Volta 2
Chiasso, Switzerland
^ ^
^ ^
FEI# 3003519143
According to information on the website, the isotretinoin is manufactured by
"Mepha Pharma"
4cnrs-skincare
Santovittorio Holdings Ltd.
PO Box 87-1008
Panama 7,
Panama
^ ^
FEI# 3006086811
RX Trust Pharmacy
Kevin Liang (admin@idig.net)
PO Box 97008
Richmond Main PO
Richmond, British Columbia V6Y 4H4
Canada
^ ^
FEI# 3006086822
Inhousedrugstore dba Inhousepharmacy
Santovittorio Holdings Ltd.
Apartado 6-6305
El Dorado,
Panama
&
P.H.L.
PO Box 337
Port Vila
Vanuatu
^ ^
^ ^
FEI# 3006089036
Pharmacy Network
Azenith International LLC
Copthall PO Box 2331
Roseau
St. George, Dominica 00152
Virgin Islands
^ ^
^ ^
FEI# 3006089093
LePharmacy.com
4196864 Canada Inc.
11215 Jasper Ave.
Suite 435
Edmonton AL T5K0L5
Canada
^ ^
FEI# 3004452269
MedicineShoppePharmacy
#122, 1959 152 street
White Rock, BC V4A 9E3
Canada
License # L85 Pharmacy
Manager: Chris Lewis
^ ^
FEI# 3006090494
Panacea-Pharmacy.com
Gamma Commercial Complex
#47 Rizal Highway cor. Manila Avenue
Subic Bay Freeport, Olongapo City
Philppines
^ ^
FEI# 3006090496
Deca-Sustanon.com
Karznik, David
Petrova,
Wroclaw, 5548
Poland
^ ^
FEI# 3004452189
Canada Drug Delivery
5765 Turner Road, Suite 233
Nanaimo BC, V9T 6M4
Canada
^ ^
FEI# 3005268261
Discount Prescription Drugs Online
Domain Discreet
P.O. Box 278
Yarmouth, N8 B5A 4B2
CANADA
^ ^
FEI# 3006090568
Pharmawest Pharmacy Ltd
Unit #101 20560 56th Ave
Langley, BC, Canada
V3A 3Y8
^ ^
FEI# 3004036103
My-drugs.ca
P.O. Box 370
1250 University Street
Montreal, Quebec H3B 3BO
Canada
^ ^
^ ^
^ ^
^ ^
^ ^
^ ^
FEI# 3004452174
PRODUCT/PRODUCT CODE SOURCE COUNTRY
Clozapine All All
65V[][]13 2/8/07
Other names: Clopine, Clopsine, Clozaril, Elcrit, Froidir, Lanolept, Leponex,
Lozapin, Zolapin
Foreign Websites/Firms Marketing Clozapine
Direct-RX Meds
Direct RX Meds
58
Xanthi 67100
Greece
^ ^
^ ^
^ ^
FEI# 3006090653
onlinesolution4u.com
Easystore4u
Ravi Jain
10/12/ Modul Town
Ludhiana PU, 56632
India
^ ^
FEI# 3006091360
Nice Price Pharmacy
2n Flr. Windsor House
Port Vila, Vanuatu
^ ^
FEI# 3006091381
Healthy Choice Pharmacy.COM INC
PO Box 457
Port Vila
VANUATU
^ ^
FEI# 3006091391
VrDrug.com
VrDrug.com
451 Ladprow Rd
Wangtonglang, Wangtonglang
Bangkok, Bangkok10210
Thailand
^ ^
FEI# 3006076729
Note: The above firm appears to market clozapine as well as isotretinoin.
PRODUCT SOURCE COUNTRY
Bamboo Crystal Foot Plaster Beijing Golden Herb & China
GPI: DR Health Co., Ltd.
GPI: DE 205, Huaxin Building
GPI: CO Beijing University of
3/7/07 Chemical Technology
15, Sanhuanbei Road,
Beijing 100029
China
FEI# 3005888678
Chinky Enterprises
2-4 Prat Avenue
3/F Kundamal House
Kowloon, Hong Kong
FEI# 3005866578
Although Bamboo Crystal Foot Plaster/Patches are manufactured in China, they
are shipped through either China or Hong Kong. The product is a combination
product as defined under 21 CFR 3.2(e)(1)(the pad is the device portion and
the ingredients absorbed into the pad make up the drug portion). The
product's labeling declares Bamboo Crystal Foot Plaster is a detoxifier; and
as promoted on the product's website, ^ ^
declares Bamboo Crystal Foot Plaster helps with constipation, eliminates
swollen veins, helps with menstrual cramps, reduces joint pain, reduces
swelling, helps with fatigue, enhances sleep as well as aid in the release of
toxins through the skin.
TR Networks Limited "Kinohimitsu detox patches"
50 MacPherson Road, #09-01 66V--99
Singapore 4/6/07
FEI # 3004126810
Web site: ^ ^
NETD Active Nutra Trading Company Blue Steel
No. 15 Yongjiang Rd. Dietary Supplement
Beilun, NETD 54Y--99
Ningbo, 315800 4/13/07
China
FEI# 2000021726
2000032670
Hindustan Lever Ltd. Fair and Lovely Cream
Unit-2, Tinsukia 786 151, Assam M.L. 53L--03
No. C-10M/2003 53L--06
Mumbai, India 4/16/07
FEI# 3006115474
Herbal Hair Regrowth Radico India
Shampoo and Serum 39-A Type-D 4/18/07
53E[][]06 HSIDC Industrial Estate
66V[][]99 88/17, Sector 31
4/9/2007 Faridabad, Haryana, India
FEI# 3001224283
Qinghai Qingzang Resource Zang Wang Shen Bao
Special Medical Co., Ltd. Capsules
809 Shunda Building No. 188 54F--99
Shunyi Road 4/26/07
Shanghai, China
FEI# 3006109242
This product is promoted on the Internet and sold at retail as a dietary
supplement for natural male enhancement. FDA analysis found tadalafil in this
product. Tadalafil is the active ingredient in the FDA approved drug Cialis.
PRODUCT SOURCE COUNTRY
(MANUFACTURER)
Han Palace Unifier Sdn Bhd Malaysia
Capsules Lot 7.13, 7th Floor 7/6/07
66V[][]99 Imbi Plaza, Jalan Imbi
54Y[][]99 55100 Kuala Lumpur
54F[][]99 FEI# 3004805836
(SHIPPER)
V-Shine Marketing Sdn Bhd Malaysia
Lot 7.13, 7th Floor 7/6/07
Imbi Plaza, Jalan Imbi
55100 Kuala Lumpur
FEI# 3005435032
This product was invoiced as a dietary supplement and found to contain
Acetildenafil, an analogue of an erectile dysfunction prescription drug,
sildenafil.
PRODUCT SOURCE
Corvalol Farmak Jsc
Korvalol 63 Frunze Street
Corvalolum Kiev, Ukraine
54F--99 (mis-declared product code) FEI #3006146593
61M--31 (correct product code)
8/24/2007
Detentions of this product should use the 502(f)(1) misbranding charge.
FDA has determined that the Corvalol product contains undeclared
Phenobarbital. The agency is aware that the product is being sold Over the
Counter (OTC) in Eastern European American communities for the treatment of
angina, chest pains, and as a sedative. This product is not approved for OTC
use in the U.S. FDA previously issued a health hazard alert for Corvalol on
July 28, 1997.
PRODUCT/ SOURCE COUNTRY
Product Code
Curaderm-BEC5 Cream All All
("BEC5 Curaderm")
62 I [][][][]
64X [][][][]
64X [][] 06 The following website on the internet are selling
Curaderm-BEC5 Cream ("BEC5 Curaderm") as a skin cream
that is a therapy for skin cancer.
IAS, c/o Les Autelets United Kingdom
Suite I, Sark Gy9 0SF
United Kingdom
^ ^
FEI#: 3006417641 8/30/07
Dr. Calmez Ltd Vanuatu
PKF House, Lini Highway
Port Vila, Sheffa 1212
Vanuatu, South Pacific
FEI # 3006417672 8/30/07
Postal Address: Vanuatu
Dr. Calmez Limited
P.O. Box 7095
Port Vila, Efate Island, Shefa Province
Vanuatu, South Pacific
^ ^
^ ^<
FEIs#:3006417654 8/30/07
WallCann IP Pty Ltd Australia
Drew Canning ^ ^<
81c Marine Parade
Seacliff
South Australia
Australia 5049
^ ^
^ ^
FEI#: 3006417663 8/30/07
Biogenesis Laboratories Order Form South Africa
P.O. Box 48119
Kommetjie 7976
South Africa
^ ^<
FEI#: 3006417666 8/30/07
PRODUCT SOURCE
The Chlamydia Treatment Cream Apis Skin Care Cream Ltd.
53L[][]03, 66V[][]99 68 Aylesford Street
09/12/07 St. Albans
Christchurch, New Zealand
FEI# 3004630781
Apis Skin Care Cream
219 Tuam Street
Christchurch, New Zealand
FEI# 3005530915
The Chlamydia Treatment Cream product is sold and promoted on the internet for
the treatment of Chlamydia. [www.chlamydia-cream.com] Based on its intended
uses, this product is a drug. Further, CDER is not aware of any substantial
scientific evidence that this product is generally recognized as safe and
effective for the conditions recommend or suggested in its labeling.
PRODUCT/ SOURCE COUNTRY
Product Code
Website for Nu Eyes:
"Nu-Eyes" & Website Registrant: Seychelles
"Can-C Eyedrops" Bionational Pharmaceuticals 9/12/07
55RP12 POB 998, 1st Floor, Office 14
66[][]V Trinity House
54[][]Y Victoria, Mahe
55QP58 Seychelles
^ ^
FEI# 3006434908
Website Contact Address: United Kingdom
Bionational Ltd. 9/12/07
Unit 34 Uplandside,
Manor Road
Clopton,
Woodbridge IP 13 6SH
United Kingdom
FEI# 3005459508
Can-C Eye drops
Website registrant: United Kingdom
Pharm-Assay International Limited 9/12/07
The Gemini Building
Houghton Hall Park
Dunstable, Beds LU5 5GB
United Kingdom
Admin/Tec Contact: Damien Trevatt
^ ^
^ ^
^ ^
^ ^
^ ^
FEI # 3004104373
Website registrant: United Kingdom
I.A.S. Limited 9/12/07
c/o Les Autelets
Suite I, VA GY9 OSF
United Kingdom
^ ^
FEI # 3006435049
Website Contact Address: United Kingdom
IAS 9/12/07
Les Autelets
PO Box 6
Sark GY9 0SF
Great Britain
FEI# 3006417641
License Holder:
International Antiaging Systems United Kingdom
PIL Gemini Building 9/12/07
Houghton Hall Park
Beds LU5 5GB
England 01582
FEI# 3006435366
PRODUCT SOURCE
Virus Sin Health Industrias Biologicas
Plus Combination Sin Fin S.A. DE C.V.
Dietary Supplement Calle de Edzna No. 106
54H[][]06 Colonia Independencia
9/13/07 Delgado Benito Juarez
C.P. 03630, Mexico D.F.
Mexico
FEI# 3004483676
This product which was entered as a dietary supplement was labeled to contain
"caustic liquid rayon" and was found to have a very basic pH. There are also
multiple drug claims for the product on the firm's website.
PRODUCT SOURCE
Jiaoli Miraculous Cream, Harbin Gelidai Cosmetics Company Ltd.
Day and Night Whitening No. 69 Erdao Street
53L[][]03, 53L[][]99 Nanyuan, China
66[][][] FEI# 3005419167
09/14/07
Website: ^ ^
Administrative contact/Registrant:
Nellie Era Saa
37 Pearl St. Donna Juana
Subdv. Rosario
Pasig City, Philippines 1609
Note: Product has been found to contain Mercury, which can constitute a health
hazard. Additionally the website promotes and sells this product for drug
use. There is no substantial scientific evidence that this product is
generally recognized as safe and effective for the conditions recommended or
suggested in its labeling.
PRODUCT/PRODUCT CODE FIRM NAME AND ADDRESS
Diabe Cinn Capsules OTC Pharma International BV
54Y--99 Edisonweg 22
66V--99 NL 4207, Gorinchem
10/9/07 Netherlands
FEI# 3004188169
This product is expressly labeled for People with Type II diabetes for
treating the characteristic signs and symptoms
(lowering blood sugar and increasing insulin sensitivity) of this
disease.
PRODUCT SOURCE
Spirulina Tablets Spirulina International BV
54A--99 Edisonweg 22
54Y--01 NL-4200, Gorinchem
10/9/07 Netherlands
FEI# 3002781920
This product's labeling includes structure, function or disease claims
including speeding up recovery from illness. Also one of the directions for
use involves topical application which takes it out of the dietary supplement
classification for that use.
PRODUCT SOURCE
Trim-Caps Ercorlat E.I.R.L.
Dietary Supplement Alfredo Salazar 228
54F--99 Miraflores
11/20/07 Lima, Peru
FEI #3005185816
This product is sold at retail as a dietary supplement containing papaya
extract, garlic and other ingredients. FDA analysis found furosemide in this
product. Furosemide is the active ingredient in the FDA approved drug Lasix
and twenty-nine other drug products.
PRODUCT SOURCE COUNTRY
Nivea Good-bye O'Will Corporation Japan
Cellulite Patch 2-13-12, Hirakawa-cho,
53[][][][] Chiyoda-ku
66V[][]99 Tokyo 1020093
12/5/07 FEI# 3005438433
REASON FOR ALERT: Product has been previously submitted for import
misdeclared and product coded [53LF[]06] as a moisturizing cosmetic. The
product labeling states "Continuous Release Diffusion continue" and that the
product "continuously releases one of its ingredients into the fatty tissue of
the skin."
The OTC monograph system does not include "timed release" or "sustained
release" drug products, a dosage form that is designed to release the
ingredients over a prolonged period of time. All products in timed release
dosage form are new drugs requiring approved applications [see 21 CFR
310.502(a)(14)].
PRODUCT SOURCE COUNTRY
Block & White Sara Lee Philippines, Inc. Philippines
Papaya Whitening Insular Life Corporate Centre
Lotion Filivest Corporate City
53L[][]06 Alabang, Muntinlupa City
66V[][]99 Philippines
1/3/08 FEI# 3003995293
Block & White
Radiance Lotion SPF10
53L[][]06
66V[][]99
1/3/08
Block & White
Ultima Skin Perfecting
Whitener
53L[][]06
66V[][]99
1/3/08
REASON FOR ALERT: The Block & White skin creams are unapproved new
drugs based upon their skin bleaching claims and are also misbranded for
failure to bear an ingredient statement.
PRODUCT SOURCE COUNTRY
Progesterone Creme Matol Botanical International Ltd, Canada
65J[][]31 290 Labrosse Avenue, Pointe-Claire,
2/6/08 Quebec, Canada
FEI# 3003478937
Allgesic Dietary Advanced Orthomolecular Research, Canada
Supplement 9-4101 19th Street NE, Calgary,
54A[][]03 Canada
54Y[][]99 FEI# 3004288965
2/6/08
PRODUCT SOURCE COUNTRY
Kalawalla Herbal Supplement Organic Hope Honduras
Immuno C Food Supplement Casa 5 Block B
66V[][]99 Tegucigalpa
54F[][]99 Honduras
3/13/08 FEI# 3006350612
Kalawalla Herbal Supplement Chemical Manufacturing Honduras
Immuno C Food Supplement and Exporting Company
66V[][]99 Km. 8 Desvio Cantarranas
54F[][]99 Tegucigalpa, Honduras
3/13/08 FEI# 3004279042
Diabetin (Ampoules) Laboratoire Manuves, Canada
61PBL99 880 Selkirk, Pointe-claire, QC,
54F[][]45 Canada
3/13/08 FEI# 3006603941
Manufacturer listed on the label Canada
Diabetin (Ampoules) Pharmavigor,
61PBL99 11750 Av 4e, Montreal, QC,
54F[][]45 Canada
3/13/08 FEI# 3003420847
Hiruval 35 Cream Vimex Pharma Inc, Canada
63V[][]99 21951 Vanneck Rd,
3/13/08 Ilderton, ON,
Canada
FEI# 3003463724
^ ^
PRODUCT SOURCE COUNTRY
Dietary Supplment Spc Inc, Canada
Restless Legs 2446 Bank Street Suite 424,
54Y[][]99 Ottawa, ONTARIO, Canada
3/27/08 FEI# 3006658197
Seigen Lactobacillus A.L.A. Corporation, Japan
Fermented Extracts 651 No, Tokyo,
66V[][]99 Japan
3/27/08 FEI# 3003535254
PRODUCT SOURCE COUNTRY
KPC-25 Capsules Taian Zhongxin Lingzhi Technology China
Optimum Female Enhancer and Development Co., Ltd.
54F[][]99 Peitianmen Street
54Y[][]99 New and High-Tech Development Zone
4/7/08 China
FEI# 2000034470
KPC-25 Capsules
Optimum Male Enhancer Taian Zhongxin Lingzhi Technology China
54F[][]99 and Development Co., Ltd.
54Y[][]99 North of Road No. 5
4/7/08 High and New Development Zone
Taian, CN-37, 271000
China
FEI# 3005380922
These products are promoted as dietary supplements for male and female sexual
enhancement. FDA analyses found sildenafil in these products. Sildenafil is
the active ingredient in the FDA approved drug Viagra.
PRODUCT SOURCE COUNTRY
Neurofosfaton Combisa Laboratorios El Salvador
Infantile Syrup 428 Carret A San Marcos
54Y[][]99 San Salvador, El Salvador
54A[][]03 FEI# 3005069146
4/17/08
PRODUCT SOURCE COUNTRY
Nattokinase Advanced Orthomolecular Research, Canada
54Y[][]99 9-4101 19 Sreet NE,
5/28/08 Calgary, Canada
FEI# 3004288965
^ ^
PRODUCT/PRODUCT CODE: FIRM NAME AND ADDRESS: COUNTRY:
Super Shangai/Strong Beijing Jianyang Health Product China
Testis Capsules Co., Ltd.
54F--99 Liren Street
54Y--99 Beijing, China
5/28/08 FEI# 2000025150
Shangai Ultra/Shangai Xuan Zhan Jin Xing
Ultra X Capsules Yuan Hutian Developing Area
54F--99 Huaihua City
54Y--99 Hunan Province
5/28/08 China
FEI #3006296075
Lady Shangai Capsules
54F--99
54Y--99
5/28/08
Shangai Regular/ Dan Wu Xin Xing
Chaojimengnan Tablets Yuan Hutian Developing Area
54F--99 Huaihua City
54Y--99 Hunan Province
5/28/08 China
FEI# 3006597012
Li Xiang Jin Xing
Yuan Hutian Developing Area
Huaihua City
Hunan Province
China
FEI# 3006597021
These products are promoted as dietary supplements for men and women. FDA
analyses found sildenafil and taladafil in these products. Sildenafil is the
active ingredient in the FDA approved drug Viagra. Taladafil is the active
ingredient in the FDA approved drug Cialis. These drugs are only approved to
treat erectile dysfunction (ED) as indicated in the FDA approved drug
applications.
PRODUCT SOURCE COUNTRY
Intrauterine Device, SMB Corporation of India India
[IUD] Copper T; 13,33,34,35,36 Prem Industrial
All models Estate, Subhash Road,
85H[][]DT Jogeshwari (East)
65J[][]36 Mumbai 400060
5/28/08 FEI# 3005135560
REASON FOR ALERT: IUDs for the purpose of contraception are regulated
as medical devices; however, IUDs for the purpose of contraception that
incorporate heavy metals, such as copper, drugs, or other active substances
are regulated as drugs. The SMB IUDs are new drugs requiring approved
applications [see 21 CFR 310.502].
PRODUCT SOURCE COUNTRY
REVLIMID All All
(lenalidomide)
61C[][]03
5/29/08
REASON FOR ALERT: Revlimid may only be marketed and used under a restricted
distribution program approved by FDA because of the potential for birth
defects resulting from exposure of this product to a developing fetus. Under
the restricted distribution program, only prescribers and pharmacists
registered with the program are able to prescribe and dispense the product.
In addition, Revlimid must only be dispensed to patients who are registered
and meet all the conditions of the risk management plan. CDER has learned
that overseas pharmacies may be importing this product into the U.S. directly
to U.S. citizens.
Shipments of Revlimid are inappropriate for release under the personal
importation policy.
PRODUCT SOURCE COUNTRY
Roberts Edward Cook and Company United Kingdom
Medicated 8 Salisbury Square
Soap London, United Kingdom
66V[][]99 FEI# 3002480794
7/3/08
REASON FOR ALERT: The term "Medicated" and the active ingredient, "potassium
mercuric iodide solution," on the labeling represents and suggests that the
product is intended for "drug" use(s). The immediate container label also
identifies the product for removing unsightly pimples, spots, dandruff, scurf
and other parasites, left free of infection, prevents sickness from spreading,
and stops any irritation. These are "drug" claims under 201(g)(1) which
defines a drug as "articles intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in man or other animals "
Crusader Elliot Irving Ltd. United Kingdom
Medicated 9 Newton Place
Soap Glasgow, United Kingdom
66V[][]99 FEI# 3000227446
7/3/08
REASON FOR ALERT: The term "medicated" and the active ingredient, "potassium
mercuric iodide solution," on the labeling represents and suggests that the
product is intended for "drug" use(s). These are "drug" claims under
201(g)(1) which defines a drug as "articles intended for use in the diagnosis
, cure, mitigation, treatment, or prevention of disease in man or other
animals "
PRODUCT SOURCE COUNTRY
Cell Pro Line Omnimedica Ag. Switzerland
Nasal Spray & Laettenstrawwe 27
Oral Tablets Schileren, Switzerland
66V[][]99 FEI# 3006487532
7/3/08 ^ ^
REASON FOR ALERT: The labeling as well as internet includes drug claims that
this product "relieves migraine, extremely powerful anti-inflammatory allergy
headaches and related symptoms", therefore, this product is a drug under
201(g)(1), which defines a drug as "articles intended for use in the
diagnosis, cure, mitigation, treatment, or prevention of disease in man or
other animals "
PRODUCT SOURCE COUNTRY
To-to Skin Smooford International, Ltd. Nigeria
Soap To-to Villa, Box 41
66V[][]99 Iperu-Remo, Ogun State, Nigeria
7/3/08 FEI# 3006761252
REASON FOR ALERT: The labeling on this product makes several disease claims.
On the "Indications/Claims" label it states that the product should be used
for ringworm, scabies, and pediculosis capitis, which is a parasitic
infection. Thus, this product is a drug under 201(g)(1), which is defined as
"articles intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease in man or other animals ".
PRODUCT SOURCE COUNTRY
Tetmosal Jagal Pharma Ltd. Nigeria
Soap Jagal Road
66V[][]99 Oregun, Lagos, Nigeria
7/3/08 FEI# 3003229596
REASON FOR ALERT: The labeling on this product makes a disease claim. The
label states, "use in place of toilet soap for both prevention and treatment
of scabies." Thus, this product is a drug under 201(g)(1), which is defined as
"articles intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease in man or other animals ".
PRODUCT SOURCE COUNTRY
Medicated Pz Industries Nigeria
Powder 45/47 Town Planning Way
(Mentholated) Ilupeju, Nigeria
66V[][]99 FEI# 3006749033
7/7/08
REASON FOR ALERT: The term "Medicated on the labeling represents and suggests
that the product is intended for "drug" use(s). The immediate container label
also identifies the product for antiseptic use and to treat prickly heat.
These are also "drug" claims under 201(g)(1), which defines a drug as
"articles intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease in man or other animals.
PRODUCT SOURCE COUNTRY
Albabukum Copac Nigeria Ltd. Nigeria
Powder Plot K6, Apapa-Oshodi Expressway
(aspirin and Lagos, Nigeria
Caffeine FEI# 3006742008
66V[][]99
7/7/08
REASON FOR ALERT: This product is labeled to contain 100 sachets, each sachet
containing acetylsalicylic acid 760 mg, and caffeine 60 mg. This product is
indicated for fast relief of pain, cold, headache and feverishness.
There is yet no final monograph for internal analgesics. However, this and
all other internal analgesic OTC drug products are required to bear certain
labeling including the drug facts format (21CFR 201.66), the Reye's Syndrome
Warning (21CFR 201.314). This product also does not comply with the tamper
evident packaging requirements for OTC drugs (21CFR 211.132).
PRODUCT SOURCE COUNTRY
Tokpela's Mist 8 Knot Co., Ltd. Japan
[bottled water] 3-7-21 Minamisuita, Suita City
29W[][]02 Osaka, Japan
29W[][]01 FEI# 3006715094
29Y[][]99
66V[][]99 8 Knot Co., Ltd. Japan
7/25/08 1339-1 Aza Minami Kawahara
Yasuikawa, Shin Asahi-cho
Takashima, Japan
FEI# 3005369655
REASON FOR ALERT: A pamphlet accompanying the product claims:
- "Tokpela's Mist eliminates ROS* (Reactive Oxygen Species) is
believed to cause conditions including cancer, high blood
pressure, diabetes, kidney disease "
- "Tokpela's Mist makes stressed erythrocytes "Red Blood Cells"
(RBC's) more flexible. RBC's ... can then effortlessly pass
smoothly through our capillaries . RBC's accordingly can quickly
carry oxygen to our extremities ."
Although "Tokpela's Mist (Miracle Water)" appears to be sold as a food, in
that its label bears a Nutrition Facts panel, the above claims cause the
product to be a new drug.
PRODUCT SOURCE COUNTRY
Piccan Teething Remedy Ipca Laboratories Ltd. India
66V[][]99 48 Kandavli Ind. Estate
08/22/08 Kandivli (West)
Mumbai, India
FEI # 3003335665
The combination of paracetamol (acetaminophen) and diphenhydramine has not
been evaluated under the OTC Drug Review for use in relieving children's
teething pain and associated troubles. The labeling contains
structure/function claims, such as using the product to relieve children's
teething pains, making this product a drug under 201(g)(1) of the FFDCA.
Further, we are not aware that this drug is generally recognized as safe and
effective for its labeled uses. Consequently, this drug appears to be a new
drug.
PRODUCT SOURCE COUNTRY
PainNot Patch Shantou Wuhuan Pharmaceutical Co Ltd. China
60L[][]99 Pujian Road, Longxin District
9/3/08 Shantou City, Guangdong Province
China
FEI# 3005354975
NOTE: Claims of "Pain Relieving Patch For temporary relief of minor aches &
pains Works in 10 minutes to relieve pain " and "Relieves pain from arthritis,
back, bursitis, carpal tunnel, tendonitis, sprains, strains, and more " were
found during review of labeling for the product and the internet website for
the initial distributor, Suarez Corporation. Also, review of the formulation
found that it did not match the Tentative Final Monograph for OTC External
Analgesics.
PRODUCT/PRODUCT CODE: FIRM NAME AND ADDRESS: COUNTRY:
Phyto Shape Capsules Etumax Corporation Sdn Bhd. MALAYSIA
54F[][][][] No. 102 Jalan Gasing
54Y[][][][] Seksyen 5, Petaling Jaya
9/16/08 46000 Selangor
Malaysia
FEI# 3005109004
3006357520
3006375686
3006380113
Etumax Tongkat Ali
Power Plus
54Y[][][][]
54F[][][][]
11/12/08
This product is promoted as dietary supplement for weight loss. FDA analysis
found rimonabant in this product. Rimonabant is the active ingredient in
Zimulti. Zimulti is an anti obesity drug not approved in the United States.
This product was found to contain undeclared Sildenafil, an erectile
dysfunction prescription drug.
PRODUCT SOURCE COUNTRY
Medicated Powder PZ Nigeria Limited Nigeria
(mentholated) (aka Pz Industries)
"Robb Ointment" 45/47 Town Planning Way
66V[][][][] Ilupeju, Nigeria
9/16/08 FEI# 3006742009
NOTE: Labeling on the product does not differentiate between active and
inactive ingredients and the listed ingredients are not recognized as approved
active ingredients for nasal decongestion under the monograph.
PRODUCT SOURCE COUNTRY
Manufacturer:
Ashton & Parsons Glaxo Smith Kline Nigeria
Matricaria Nig Plc Igbesa Road
66V[][][][] Agbara, Nigeria
9/16/08 FEI# 3006742011
Shipper:
Salawu Enterprises Ltd. Nigeria
10 Onikosi Street
Otta, Nigeria
FEI# 3004526255
NOTE: The product is labeled to contain tincture of matricaria, is indicated
for teething and slight stomachic upsets during infancy, and FDA is not aware
that the product is generally recognized as safe and effective for its labeled
uses.
Jiangxi Gaoan Tea Co., Healing Collection 4 Tea 9/24/08
Ltd. 31K[][]99
Qiao Bei Road, 54E[][]99
Gao An City, 66V[][]99
Jiangxi, China (Mainland)
FEI# 3004273888 Diabetic Choice Tea 11/12/08
31K[][]99
REASON FOR ALERT: Labeling of this herbal product makes drug claims related to
the mitigation of cholesterol, diabetes and high blood pressure thus causing
the product to be a new drug for which no approval is in effect.
NOTE: Product may be entering as a dietary supplement, therefore, we have
included the product code "54E[][]99" along with the appropriate drug code
"66V[][]99" and the product code used in the entry for which this firm was
added "31K[][]99."
PRODUCT SOURCE
"Chinese Love Stone" Tsang Fook Kee Medicine Co. 9/29/08
"Rock Hard" 5, G/F, Ko Shing Street
"Black Stone" Hong Kong
"Stud 100" FEI# 1000231335
GPI=DR
GPI=VI
54Y[][]99
54F[][]99
66V[][]99
Note: Product has been found to contain the toxin Bufotenine, which is
classified by DEA as a Schedule 1 drug.
PRODUCT SOURCE
Pop Face Polish (AHA) Pop Inc.
53L[][]03 Unknown Street Address
GPI=DR Bangkok, Thailand
11/12/08 FEI# 3006948477
PRODUCT SOURCE
Acne Solutions Herbal Solutions Health, S.A. de C.V.
Herbal Capsules Jesus Garcia No. 388-B Zona Centro
54E[][]99, 54F[][]99 Irapuato, Mexico 36500
54Y[][]99,66V[][]99 FEI# 3006484715
GPI=DR
11/12/08
Clear and Balance Herbal Solutions Health, S.A. de C.V.
Facial Gel Jesus Garcia No. 388-B Zona Centro
GPI=DR Irapuato, Mexico 36500
11/12/08 FEI# 3006484715
PRODUCT SOURCE
Neutrotone Cream Orange Drugs Ltd.
64L[][]67 66/68 Town Planning Way
11/12/08 Ilupeju
Lagos, Nigeria
FEI# 3006755325
PRODUCT SOURCE
CiCi Natural Herbal Beijing Yin Han Health Products
Capsules Manufactory Inc.
GPI=VI Wang Xin Zhuang Zhen Le Yuan Lu 29 Hao
GPI=DR Ping Gu District
11/12/08 Beijing, China
FEI # 3006531677
This product was found to contain an undeclared drug called aminotaladafil, an
analog of taladafil, an erectile dysfunction prescription drug.
PRODUCT SOURCE
Uptrol Dietary Supplement Natural Health Products
aka Uptrol Male- Office 8 The Village
Enhancement Formula Dubai, United Arab Emirates
GPI=VI FEI# 3005114054
GPI=DR
11/12/08
This product was found to contain an undeclared drug called taladafil, an
erectile dysfunction prescription drug.
PRODUCT SOURCE
Maxi-Peel Exfoliant Splash Corporation
53L[][]03 17F Lazaro Street Canumay West
66V[][]99 Valenzuela City, Philippines
11/18/08 FEI# 3004096041
PRODUCT SOURCE
Aloe Vera Cream Vitus Pharm Co.
(Clobetasol Propionate) Unknown Street Address
GPI=DR Milan, Italy
11/18/08 FEI# 3002939833
PRODUCT SOURCE
Sulpher Ointment Associated Pharm/Food & Chemical Ltd.
GPI=DR Eziama Industrial Estate
11/19/08 Lagos, Nigeria
FEI# 3006804324
Aboniki Balm Global Industries Nigeria Ltd.
GPI=DR 41 Egbon Street
11/19/08 Ugowo, Benin City, Nigeria
FEI# 3006780965
Detox Foot Patch Sanzi Cosmetics
GPI=DR (dba Guangzhou Sanzi Cosmetics)
11/19/08 5 Pine Park
New City, Guangzhou, China
FEI# 3006850529
Li Da Dai Dai Hua Kunming Dali Industry & Trade Co., Ltd.
Slimming Capsules No. 372, West Renmin Road
GPI=VI Kunming, Yunnan, China
GPI=DR FEI #2000033137
12/1/08
This product was found to contain an undeclared drug called Sibutramine, the
active ingredient in the FDA approved anti-obesity drug Meridia.
ATTACHMENT (B) TO IMPORT ALERT #66-41 1/23/07
Unapproved New Drugs That May Be Subject to DWPE
***ATTACHMENT B: "AYURVEDIC DRUGS"
PRODUCTS: Ayurvedic, a/k/a: Pushpapdhanwa, etc.
PRODUCT CODE: New Product Code for Ayurvedics TBD
54F[][]99
54Y[][]99
PROBLEM: Unapproved drugs
PAC: AAP
PAF: 56008H
COUNTRIES: All
MANUFACTURER/SHIPPER: All Firms and Products Listed
CHARGES: For finished products that appear to be intended for
use as drugs: "The article is subject to refusal of
admission pursuant to section 801(a)(3) in that it
appears to be a new drug under the meaning of section
201(p) without an effective new drug application, as
required by section 505. [Unapproved new drug,
section 505(a)]"
REASON FOR ALERT: A number of ayurvedic drugs may present a serious
health hazard to the user because they may contain
heavy metals such as lead, mercury, and arsenic.
Heavy metals pose a particular health risk because
they may accumulate in vital organs. For example,
arsenic poisoning can cause nausea, abdominal pain,
vomiting, severe diarrhea, neuropathy, dermatitis,
heart abnormalities, kidney or liver damage, and
reduced motor nerve function. Lead poisoning can
cause fatigue, irritability, insomnia, nerve
disorders, muscle and joint pain, memory and
concentration problems, dizziness, seizures, and
coma. Mercury poisoning can cause fatigue, headache,
muscle weakness, joint pain, tremors, irritability,
concentration problems, slowed sensory and motor nerve
function, and reduced mental function. Children are
particularly at risk from the toxic effects of heavy
metals.
BACKGROUND: A December 15, 2004, article published in the Journal
of the American Medical Association (JAMA) reports
that of 70 ayurvedic drugs sampled and tested, 14
(20%) were found to contain potentially harmful levels
of lead, mercury, and/or arsenic. These products were
produced in South Asia and were purchased in South
Asian grocery stores locatedin Boston, Massachusetts.
In July 2005, Health Canada tested a number of
ayurvedic products available in the Canadian market
and determined that they contained high levels of
lead, mercury, and/or arsenic. In August 2005, the
Department of Health, City and County of San
Francisco, tested a number of ayurvedic products that
had been consumed by an individual who suffered severe
lead poisoning and found that the products contained
elevated levels of lead. In 2003, the Santa Clara
County Department of Health, in California, tested
Pushpadhanwa, an ayurvedic product that was associated
with two incidents of injury, and found the product
contained high levels (8%) of lead.
GUIDANCE: Most imported ayurvedic products are marketed as
drugs. Some ayurvedic products are imported as
dietary supplements. These products are
distinguishable by the fact that their labels contain
the statements "Dietary Supplement" and the disclaimer
required for dietary supplements. Districts
encountering ayurvedic products labeled as dietary
supplements should consult with CFSAN for guidance.
All ayurvedic drug products subject to this Import
Alert are intended for ingestion, are labeled in
English and Hindi, or totally in Hindi. Under the
Federal Food, Drug, and Cosmetic Act (Act), a drug is
an article intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease. 21
U.S.C. 321(g)(1)(B). A drug is likewise an article
(other than food) intended to affect the structure or
any function of the body. 21 U.S.C. 321(g)(1)(C).
Ayurvedic products that are not dietary supplements
can still be drugs if they do not bear disease claims
but are intended to affect the structure or any
function of the body. Drugs that contain heavy metals
(other than minor unavoidable trace amounts found in
some drugs) are not generally recognized as safe and
effective for any indication. Therefore, these
products are "new drugs" within the meaning of section
201(p) of the Act. Since these products are not the
subject of an approved new drug application (NDA),
their importation into the United States violates
section 505(a) of the Act. The products listed in the
attachment are the ayurvedic products that were tested
and found to contain heavy metals as described above.
Districts may detain without physical examination any
shipments of the finished ayurvedic drugs listed in
the attachment. Discretionary release of these
products under the Personal Importation guidance of
Chapter 9 of the Regulatory Procedures Manual (RPM)
may not be appropriate.
KEYWORDS: Ayurvedic; Bal Chamcha; Bala Guti; Bala Sogathi;
Balguti Kesaria; Gesari; Karela; Maha Sudarshan
Churna; Mahalakshmi Vilas Ras; Swarnna Mahayograj
Guggulu; Navratna Rasa; Safi; Shilajit; Pushpadhanwa;
Ayurvedic Drugs That Have Been Found To Contain Heavy
Metals
PRODUCT: MANUFACTURER:
Bal Chamcha Jalaram
62 Midc Area
India
FEI# 3003440655
Bala Guti The Zandu Pharmaceutical Works
Maha Sudarshan Churna Ltd., GIDC, Plot No.82, Uapi
Gujarat, India
FEI# 3005378718
Bala Sogathi, Navjeevan Ayurvedic
515/17, Manlana Azad
Nallbazaar, Mumbai, India
FEI# 3005378729
Balguti Kesaria Kesari Ayurvedic Pharmacy
Abrama, VIA Vedchha
Gujarat, India
FEI# 3005378744
"Diabet Guard" Granules The Himalaya Drug Company India
"Himalaya Diabecon" Makali, Tumkur Road
54Y[][]99 Bangalore, Karnataka
54F[][]99 India
FEI # 3004259394 1/23/07
FEI # 3004681347
Goodcare Pharma Pvt. Ltd. India
1, Gupta Lane
Calcutta, West Bengal
India
FEI # 3005383147 1/23/07
^ ^
Gautam Global Also DBA Botanika India
34 Old Cannought Place
Dehradun
India
FEI # 3003507632 1/23/07
^ ^
^ ^<
Rave Overseas Pvt. Ltd India
P O Box No. 611, GPO
Indore
India
FEI # 3006074168 1/23/07
^ ^<
Gesari Harinarayan Pharmacy
India
FEI# 3005378957
HSY 103 Harbhajan Singh Yogi & Sons,
Chandigarh, India
FEI# 3005378967
Herbal Ayurvedic Medicine Shree Baidyanath Ayurved Bhawan Ltd
62QBY99 Gwalior Road, Jahansi
8/25/06 India
FEI# 3003175278
Karela The Himalaya Drug Company
Makali, Bangalore, India
FEI# 3002535359
Maha Sudarshan Churna Dabur India Limited
P.O. Daburgram, Bihar
New Delhi, India
Zandu, India;
FEI# 3003618623
Mahalakshmi Vilas Ras with gold Ayurved Bhawan Limited
Gwalior Road
Jhansi, India
FEI# 3003199854
Majayograj Guggulu w/silver & Baidyanath Aywued
Makardhwaj Jhansi, India
Swarna Mahayograj Guggulu with gold FEI# 3004149275
Navratna Rasa Unjha Ayurvedic Pharmacy
India
FEI# 3005379055
Pushpadhanwa tablets Shree Dhootapapeshwar Ltd.
135 Nanubhai Desai Road
Mumbai, India
FEI# 3002945659
Safi, Blood Purifier Hamdard (WAKF) Laboratories
B/1-2 111 Industrial Area
Ghaziabad, India
FEI# 3004659877
2000027663
Hamdard Laboratories
Hamdard, Pakistan
FEI# 3005339043
Shilajit Syncom Formulations Limited
Factory: 256-257, Sector 1,
Pithampur (Dhar), Caves Road,
Andher, Mumbai, India
FEI# 3005379096
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