IA #66-57 - 1/27/92, "DETENTION WITHOUT PHYSICAL EXAMINATION OF FOREIGN
UNAPPROVED PRESCRIPTION DRUGS", ATTACH, 6/5/07
TYPE OF ALERT: DETENTION WITHOUT PHYSICAL EXAMINATION
NOTE: This import alert represents the Agency's current guidance
to FDA field personnel regarding the manufacturer(s) and/or
products(s) at issue. It does not create or confer any
rights for or on any person, and does not operate to bind
FDA or the public.
PRODUCT: FOREIGN MANUFACTURED UNAPPROVED PRESCRIPTION DRUGS
PRODUCT CODE: 66 [][][][][]
HARMONIZED
CODE: N/A
PROBLEM: New drug without an approved New Drug Application (NDA)
(DRND)
PAF: AAP
COUNTRY: ALL
MANUFACTURER/
SHIPPER: See Attachment
MANUFACTURER
SHIPPER I.D.#: N/A
IMPORTER'S
I.D.#: N/A
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 approved new drug
application [Unapproved New Drug, Section 505(a)]."
OASIS CHARGE
CODE: UNAPPROVED
RECOMMENDING
OFFICE: HFC-131
REASON FOR
ALERT: FDA has observed an increase in the promotion and
importation of unapproved prescription drugs of foreign
origin.
Unapproved prescription drugs present serious safety and
effectiveness concerns. Moreover, approved U.S. versions of
these drugs are available. Therefore, this import alert is
being established to provide a listing of known
distributors.
GUIDANCE: Districts may detain without physical examination all dosage
forms and shipments, commercial and personal, of foreign
manufactured unapproved prescription drugs from distributors
listed in the attachment. Districts should determine whether
the drugs are covered by a current approved NDA or IND.
FDA has concluded that shipments of these foreign
manufactured unapproved prescription drugs are inappropriate
for release under the personal importation policy.
FOI: No purging is required
KEYWORDS: NEW DRUG (NDA), Prescription Drugs
PREPARED BY: Ted Poplawski, DIOP, 301-443-6553 ATTACHMENT IMPORT ALERT #66-57 Revised 6/5/07
DISTRIBUTORS OF FOREIGN MANUFACTURED UNAPPROVED PRESCRIPTION DRUGS PROMOTED TO
INDIVIDUALS IN THE U.S.
PRODUCT SOURCE COUNTRY
ALL PRESCRIPTION INTERPHARM, INC. NASSAU,
DRUGS INTERNATIONAL BAHAMAS
PHARMACY
ALL PRESCRIPTION NORTHAM Medication NASSAU,
DRUGS Service BAHAMAS
International
Pharmacy
ALL PRESCRIPTION INHOME HEALTH DELEMONT,
DRUGS SERVICES SWITZERLAND
** Denotes firms that ship for Inhome Health Services
** ALL PRESCRIPTION M. BOURQUIN BELGIUM
DRUGS P.O. BOX 108 9/29/92
ANTWERP, BELGIUM
** ALL PRESCRIPTION ZITA TROS BELGIUM
DRUGS P.O. BOX 108 9/29/92
ANTWERP, BELGIUM
** ALL PRESCRIPTION N. CLAN OR E. CLAES BELGIUM
DRUGS P.O. BOX 108 9/29/92
ANTWERP, BELGIUM
** ALL PRESCRIPTION MARGARET EDEN BELGIUM
DRUGS AMERICALEI 159 10/26/92
B.82 B-2000
BELGIUM
PRODUCT SOURCE COUNTRY
** ALL PRESCRIPTION F.J.M. BORKING NETHERLANDS
DRUGS VINKEVEEN, 9/29/92
DOOAARSLAN 90
NETHERLANDS
** ALL PRESCRIPTION UNKNOWN AMSTERDAM
DRUGS P.O. BOX 70385 9/29/92
NETHERLANDS
** ALL PRESCRIPTION S. KESSLER BELGIUM
DRUGS AMERICALEI 159 9/29/92
B.82 B-2000
ANTWERP
PERGONAL AND BIOMEDICAL HOLDING ARUBA AND
METRODIN A.V.V. CURACAO,
NETHERLANDS
ANTILLES
10/2/92
ALL PRESCRIPTION QUOTZA S. A. ITALY
DRUGS VIA CERVI #6
46020 PALIDANO
(MN)
ITALY
MID# ITQUOSA6PAL
(REF:QUOTZA S.A.,
MANNHEIM, WEST
GERMANY)
PERGONAL AND BIOMED HOLDING A.V.V. CURACAO,
METRODIN GROOT KWARTIER NETHERLAND,
BOX 4469, ANTILLES
MID# NBIOHOL4469CUR 4/12/93
PERGONAL AND CURACAO SERVICES N.V. CURACAO,
METRODIN NETHERLAND
ANTILLES
3/19/93
ALL PRESCRIPTION International HANOVER,
DRUGS Products GERMANY
ALL PRESCRIPTION Quotaz S.A. West Germany
DRUGS P7, 20-21 (Planken)
D-6800 Mannheim 1
West Germany
ID# DEQUOSA2021MAN
3/13/91
*** ALL PRESCRIPTION AZTECA TRIO ZONA RIO TIJUANA,
DRUGS INTERNACIONAL MEXICO
S.A. de C.V.
*** ALL PRESCRIPTION BAJA TRIADO ZONA RIO,
DRUGS INTERNACIONAL, S.A. TIJUANA, B.C.,
DE C.V. MEXICO
4/16/93
Note: The above shipper appears to be a new name for the firm identified in
this import alert as Azteca Trio Internacional S.A. de C.V., Zona Rio Tijuana,
Mexico.
Beta-Interferon Serono Canada Inc. Canada
(Alternate Names = 5915 Airport Road
Rebif (TM) Suite 810
R-FRONE ) Mississaugua, Ontario, L4V 1T1
Canada
MID# XOSERCAN5915MIS
Beta-Interferon CORNE,S.A. de C.V. Mexico
(Trade name Rio San Lorenzo
FRONE TM) No. 623
Col. Puentes del Valle
Garza Garcia, Nuevo Leon
66220, Mexico
Manufacturer: Serono Laboratories Mexico
11/1/93
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.
ALL PRESCRIPTION INTERLAB LONDON,
DRUGS BCM BOX 5890 ENGLAND
LONDON WC1N 3XX
ENGLAND
MID #GBINT5890LON
ALL PRESCRIPTION MEDICINE CLUB OF NASSAU,
DRUGS AMERICA, INC. BAHAMAS
INTERNATIONAL 2/12/92
PHARMACY
ALL PRESCRIPTION MEDICINE CLUB NASSAU,
DRUGS INTERNATIONAL, INC. BAHAMAS
10/21/92
ALL PRESCRIPTION INTERNATIONAL UNITED KINGDOM
DRUGS ANTIAGING SYSTEMS 5/4/93
(IAS)
PO BOX 2995
MUSWELL HILL, LONDON N10 2NA
ID# GBINTANT2995MUS
PERGONAL AND EFES CORPORATION BRITISH VIRGIN
METRODIN ABBOTT BUILDING 2ND FLR ISLANDS
P.O. BOX 933 8/9/93
ROAD TOWN, TORTOLA
BRITISH VIRGIN ISLANDS
MID# VGEFECOR933ROA
ALL DRUGS A. WERNER & CO. CZECHOSLOVAKIA
P.O. BOX 615 9/23/93
111 21 PRAGUE 1
CZECHOSLOVAKIA
MID#: CSWERCO615PRA
ALL PRESCRIPTION *B. MOUGIOS AND CO. GREECE
DRUGS PITTAKOU 23 T.K. 54645
THESSALONIKI - GREECE
MID# GRMOUAND23THE
*The above firm is presently on automatic detention. However, we have been
amde aware of other names being used. Any variations to this firm name,
including, but not limited to, Georgios, Georgiadou, B&G Moyres, etc., and
also using other cities in Greece should be viewed as the same operation and
will be subject to this import alert.
STERILE OPHTHALMIC SHAH & SHAH INTRAOCULAR 4/7/95
HYDROXYPROPYL LENS (PVT.) LTD. INDIA
METHYLCELLULOSE 2% 2 RUSSELL STREET
SOLUTION USP FOR H.D. ROAD, JOKA 743512
INTRAOCULAR USE CALCUTTA 700 071, INDIA
PRODUCT CODE: 55R--14 MID# INSHASHA743CAL
FEI# 1000327725
ALL PRESCRIPTION THE ALZHEIMER'S BUYERS' SWITZERLAND
DRUGS CLUB 5/17/95
POST FACH
CH-8911 O.
RIFFERSWIL, SWITZERLAND
MID# CHALZBUYRIF
ALL PRESCRIPTION AMIMED DIRECT LTD. UNITED KINGDOM
DRUGS PO 6983 6/30/95
LONDON, ENGLAND E17 5TR
MID# GBAMIDIR6983LON
ALL PRESCRIPTION MERCANTIL FARMACEUTICA MEXICO
DRUGS PATRIA 6/30/95
NEWTON 104 COL. POLANCO
MEXICO 5 D.F.C.P.,
MEXICO, 11560
MID# MXMERFAR104MEX
ALL PRESCRIPTION Olympia Skouvara Greece
DRUGS 36 Agorakritou Street 6/30/95
Athens, 10440, Greece
FEI# 1000369562
AND
Vipharm Pharmaceutical Products 7/22/97
(OL Skouvara & Co.
82 Epamidoda Street
Thiva, 32200, Greece
FEI# 3000721937
All Prescription Drugs Innomed-Mex aka Innovaciones Mexico
Product Code-GPI-DR Medicas S.A. De C.V. 10/3/95
Protasio Tagle no. 132 A y B
colonia San Miguel
Chapultepec 11900 Mexico, D.F.
MID# MXINNMED132CHA
FEI# 1000409967
All Prescription Drugs Euro Care Mailorder Pharmacy Netherlands
Product Code-GPI-DR P.O. Box 75 8200 AB 4/16/96
Lelystad, the Netherlands
MID# NLEURCAR8200LEL
FEI# 1000496455
All Prescription Drugs P. Goudvis Netherlands
Product Code-GPI-DR Vyzelweg 32 8243 PM 4/16/96
Lelystad, The Netherlands
MID# NLGOU8243LEL
FEI# 1000535082
All prescription Pharmacie Chatel France
drugs 38 Avenue de Clichy 5/24/96
GPI-DR Paris, France
MID# FRPHACHA38PAR
FEI# 1000549885
All prescription CS Distributors S.A. Mexico
drugs de C.V. (main office) 5/24/96
GPI-DR Cordoba # 138 Col. Roma
Mexico City, Mexico
MID# MXCSDIS138MEX
FEI# 1000549924
All prescription CS Distributors S.A. Mexico
drugs de C.V. (manufacturing plant) 5/24/96
GPI-DR Av. de la Carretera No. 1335
Cd. Industrial Irapuato
Irapuato, Mexico
MID# MXCSDIS1335IRA
FEI# 1000549925
All prescription Alan Pharmaceuticals United Kingdom
drugs 204 Essex Road 5/24/96
GPI-DR London, England N1-3AP
MID# GBALAPHA204LON
FEI# 1000549879
All Prescription Afz. Fisher Netherlands
Drugs Vyzelweg 32 8243 PM 6/6/96
Product Code- Lelystad, The Netherlands
GPI-DR MID# NLGOU8243LEL
MID# NLAFZFIS8243LEL
FEI# 1000535082
Note: This name has been identified as an alternate name used on
packages shipped by P. Goudvis at the same address.
All Prescription ALP Food Supplements Netherlands
Drugs aka J.H. Agelink 6/6/96
Product Code-GPI- De Wittenkade 122-1
Amsterdam, 1051 AL
The Netherlands
MID# NLALPFOO1221AMS
MID# NLJHAGE1221AMS
FEI# 1000562753
Reason for revision: Promotional solicitations for purchasing foreign versions
of approved U.S. prescription drugs. Note: These firms have been identified as
shippers for orders made through Euro Care Mailorder Pharmacy, which is also
on detention without physical examination of import alert 66-57. ALP Food
Supplements (aka J.H. Agelink) has also been identified as soliciting
individuals through the World Wide Webb (Internet).
The following firms have been identified as providing unapproved drugs to
individuals in the U.S. through ^ ^
All Prescription Medicines International United Kingdom
Drugs P.O. Box 5217 11/22/96
Product Code GPI East Kilbride, Glasgow
G74 3XN U.K.
FEI #1000634264
MID #GMBEDINT5217EAS
All Prescription Farmacias Fantini Mexico
Drugs 20 de Noviembre 109 11/22/96
Product Code GPI Cuautitlan, Edo, Mexico
FEI #1000657469
All Prescription Baxamed Corp. Switzerland
Drugs 4 Street 4/7/97
GPI = DR Binningen, Switzerland
FEI# 3000174964
All Prescription International Merchandising Thailand
Drugs Procurement 8/4/97
(PC-DR) P.O. Box 336 (mailing address)
Phuket, 38000 Thailand
FEI# 3000953244
All Prescription Quality Health, Inc. England
Drugs 401 Langham House 12/19/97
GPI = DR 29-30 Margaret Street
London, England
FEI# 3001270608
Rx World Mexico
Tepayac 2313 Oriente 12/19/97
Colonia Hidalgo
Juarez, Chihuahua, Mexico
FEI# 3001270609
All Drugs Libertarian Solutions Hong Kong
GPI = DR GPO Box 12496 12/22/97
Hong Kong
FEI# 3001277982
All Prescription Longevity Products, Ltd. Gilbraltar
Drugs P.O. Box 561 2/20/98
GPI = DR Suite 6/588
28 City Mill Lane
Gibraltar
FEI# 3001405794
Fenfluramine Bao Shan Pharmaceutical Co. 3/23/98
Tablets of Ya Dong Pharmaceutical Co.
60R[][]08 Shanghai Institute of
Pharmaceutical Industry
1320 Beiji Road
West Shanghai,
China PROC 20040
FEI# 1000611256
PRODUCT SOURCE COUNTRY
Xenical Airport Oak Pharmacy New Zealand
60R[][]99 Auckland, New Zealand 8/4/99
FEI# 3002706517
MP & JE Gould
P.O. Box 18091
Glen Innes, New Zealand 1006
FEI# 3002692032
Cox's Pharmacy
Crn Mayfair and Line Roads
GLen Innes, New Zealand
FEI# 3002707195
All Drugs Mail Pack S.L. Spain
GPI = DR Av. De Las Nacionales Unidas 43 11/12/99
Puerto Banus, Malaga (Marbella)
Spain
FEI# 3002842636
The following firms/products were noted on their Internet web sites offering
for sale drugs which appear to be prescription drugs in the United States
(U.S.). FDA is unable to determine if the drugs marketed by these firms have
been made in accordance with the U.S. specifications and are the same product
marketed legally in the United States. Therefore, the sale and distribution
of these products on their Internet web site may be illegal in this country
(U.S.) and may be in violation of Title 21 of the United States Code, Section
331(a), 331(d) and 355(a).
All Prescription Drugs Hamada Dayateknindo, P.T. 3/14/00
Product Code = DR (aka VIAGRAGOGO.COM)
JL., Sakti II No. 15
Jakarta, Jawa 12270
Indonesia
FEI# 3002950358
FEI# 3002950510
All Prescription Drugs Global Medica 3/14/00
Product Code = DR (aka VIAGRA.nu)
Gibraltar
FEI# 3002950407
FEI# 3002950408
All Prescription Drugs Minitraders 3/14/00
Product Code = DR PO Box N-121
Nassau, Nassau
Bahamas
FEI# 3002950413
PRODUCT SOURCE COUNTRY
All Prescription Drugs World Pharmacy, Inc 3/14/00
Product Code = DR Hodges Bay
St. John, Antigua
West Indies
FEI# 3002950419
All Prescription Drugs Elina Pharmaceuticals 3/14/00
Product Code = DR (aka viagraep.com)
PO Box 633
Paphos, 8011
Cyprus
FEI# 3002950442
FEI# 3002950525
All Prescription Drugs Menscare Services 3/14/00
Product Code = DR 1 Woodgate House
Woodlane, Uttoexeter
Staffordshire, England
ST14 8JR
FEI# 3002950450
All Prescription Drugs Concept Shopping Limited 3/14/00
Product Code = DR (aka ukyes.com)
Staffordshire, Great Britain
ST6 7NG
FEI# 3002950453
FEI# 3002950525
All Prescription Drugs Lifestyle Pharmacy 3/14/00
Product Code = DR 10 King George V Street
Roseau, Dominica
FEI# 3002950462
All Prescription Drugs DMC di Vezzi Roberto 3/14/00
Product Code = DR (aka anagen.net)
Via Emilia 30
Curno, BG, 24035 Italy
FEI# 3002950464
FEI# 3002951482
All Prescription Drugs Hampstead Trust 3/14/00
Product Code = DR (aka pharmcom.com)
Mairangi Bay, Auckland
1310 New Zealand
FEI# 3002951485
FEI# 3002951486
PRODUCT SOURCE COUNTRY
All Prescription Drugs INK Electronic Media Ltd. 3/14/00
Product Code = DR (aka menspharmacy.com)
(aka pharmacy-geoff.com)
(aka unitedpharmacies.com)
(aka slimmerspharmacy.com)
(aka hairpharmacy.com)
(aka lifepharmacy.com)
(aka smokerspharmacy.com)
River Road, R.D. 1
Hamilton, Waikato
2001 New Zealand
FEI# 3002950499
FEI# 3002950434
FEI# 3002950456
FEI# 3002950430
FEI# 3002950488
FEI# 3002950471
FEI# 3002950501
FEI# 3002950475
FEI# 3002950502
FEI# 3002950477
FEI# 3002950503
FEI# 3002950478
FEI# 3002950505
FEI# 3002950479
FEI# 3002950508
ALL PRESCRIPTION DRUGS HAIR2GO 3/22/00
PRODUCT CODE = DR (AKA KERRY BELL)
P.O. BOX 52 173
AUCKLAND, NEW ZEALAND
FEI #3002957478
FEI #3002957479
ALL PRESCRIPTION DRUGS ALBANY STREET PHARMACY 3/22/00
PRODUCT CODE = DR (AKA ONLINEPHARMCY)
P.O. BOX 6104
DUNEDIN, NEW ZEALAND
FEI# 3002958432
FEI# 3002958433
ALL PRESCRIPTION DRUGS JANSEN VAN VUUREN 3/22/00
PRODUCT CODE = DR (AKA ALANTS)
8A HOWE CIRCLE
HOMESTEAD; GERMISTON
SOUTH AFRICA 1412
FEI# 3002958433
ALL PRESCRIPTION DRUGS MR. JOHN W. 3/29/00
PRODUCT CODE = DR (AKA CYBERMEDRX. COM)
P.O. BOX 17205
ATHENS, 10024, GREECE
FEI# 3002964581
FEI# 3002964580
All prescription Drugs The Somatropin Drugstore 7/31/01
GPI - DR 36 Adderly Street
Cape Town, South Africa
FEI# 3003388642
All Prescription Drugs Libertarian Solutions 7/31/01
GPI - DR c/o Mr. Dennis Faulkner
Nogal No. 7
Torreblanca Fuengirola
Malaga, Spain
FEI# 3003388645
All Prescription Drugs SamjinPharm 7/31/01
GPI - DR 338-8 Seokyo-dong, Mapo-ku
Seoul, Korea
FEI# 3003388659
All Prescription Drugs Mr. John Wong 7/31/01
GPI - DR #1 Drugstore Onlne
P.O. Box 115
Singapore
FEI# 3003388662
All prescription Drugs Crowded Planet 8/3/01
GPI - DR c/o Richard Hughes
P.O. Box 920
Wollongong (East), Australia
FEI# 3003234913
All prescription Drugs Hamid Reza Makhmalchi 8/3/01
GPI - DR SF2, Pearl Villa
6TH Cross, Sultanpalaya
Bangalore, India
FEI# 3003394508
All prescription Drugs Mags International Pvt. Ltd. 8/3/01
GPI - DR c/o Samit Chhabra
89 Nehru Place
719A Hemkunt Chanbers
New Dehli, India
FEI# 3002908017
All prescription Drugs Suthapintu Vut 8/3/01
GPI - DR P.O. Box 25, Khlongkum
Bangkok, Thailand
FEI# 3003394507
(also d.b.a. 2/12/03
MedicaPharma Corp.
2591 Ladprao 101
Khlong-Chan, Bangkapi
Bangkok 10244 Thailand
@www.medicapharma.com
FEI#3003215937)
&
(also d.b.a.
MedicaPharma Corp. 2/12/03
Post Box. 25
Khlong-Kum, Bangkok 10244
Thailand
FEI #3003194471)
All prescription Drugs Jergen Schneider 8/3/01
GPI - DR Georgenschwaig 6
Munich, Germany
FEI# 3003394505
All prescription drugs Sandoval Drugs (I-Mart) 8/3/01
GPI - DR c/o James Sandoval
84 Solmac Bldg., Suite 310-311
Dapitan Corner Banawe Sts.
Quezon City, Phillipines
FEI# 3003394491
All prescription drugs Bedessee Sporting Goods 8/9/01
GPI - DR c/o Lionel Bedessee
2350 Midland Ave.
Scarborough, Canada
FEI# 3000042659
All prescription drugs De La Web Multimedia 8/9/01
GPI - DR Exposicion, Inc.
48 Par-la-Ville Road,
Suite 812
Hamilton, Canada
FEI# 3003399751
All prescription drugs John Ten Valde 8/9/01
GPI - DR Leith Place
Tokoroa, New Zealand
FEI# 3003399752
All prescription drugs Magic of Nature 8/9/01
GPI- DR c/o Olga Buchman
P.O. Box 448
Nea-Tziona, Israel
FEI# 3003399757
All prescription drugs Dolores Brash 8/9/01
GPI - DR P.O. Box 2361
Sardis Station Main
Chilliwach, Canada V2R1A7
FEI# 3003399758
All prescription drugs Spank Products 8/9/01
GPI -DR unknown
Amsterdam, Netherlands
FEI# 3003399766
All prescription drugs JFW Enterprises 11/25/01
GPI = DR c/o John William
Angel Garcia Aburto #364
CO. Balderama
Hermosillo, Mexico 83180
FEI# 3003496517
All prescription drugs Point Douglas Pharmacy 11/25/01
GPI = DR c/o Jasmine Wong
885 Main Street
Winnipeg, Canada R2W3P2
FEI# 3003024516
All prescription drugs Planet Drugs Direct 11/25/01
GPI = DR c/o Peter Gilbert
P.O. Box 105-290
Auckland, New Zealand
FEI# 3003496671
All prescription drugs USA Medicine.com Ltd. 11/25/01
GPI = DR c/o Mark Caron
123 Sandford Wood
Swords, Ireland
FEI# 3003496532
All prescription drugs Target Zone 11/25/01
GPI = DR c/o Jean Pierre
453 Toynevale
Pickering, Canada L1W3H2
FEI# 3002926028
All prescription drugs Farmamundo 11/25/01
GPI = DR c/o Fernando Benavides
Via Volta 2
Chiasso, Switzerland
FEI# 3003236371
All prescription drugs Masters Marketing Company 11/25/01
GPI = DR c/o Z. Masters
Masters House
Harrow, United Kingdom
FEI# 3001599401
All prescription drugs Farmacia Cerati 11/25/01
GPI = DR Via Roma 17
S. Damiano d'Asti, Italy
FEI# 3002894254
All prescription drugs Pharma Group 11/25/01
GPI = DR Avd. Antonio Agusto Aguiar 17B
Suite 6
Lisbon, Portugal
FEI# 3003496537
All Rx Drugs Mediplan Health Consulting Inc 11/25/01
GPI=DR aka Mediplan Global Health 11/29/06
aka Mediplan Health Pharmacy
aka Canam Pharmacy
aka Mediplan Health
aka Mediplan Prescription Plus Pharmacy
located at:
115 Main St. South
Minnedosa, MB Canada ROJ 1EO
FEI# 3003497075
FEI# 3005895836
FEI# 3003519923
(and)
RxNorth.com
561 6th Ave. N.W.
Minnedosa, MB Canada ROJ 1EO
FEI# 3004869949
FEI# 3004079871
Websites:^
^
All prescription drugs Pharmacy International, Inc. 11/25/01
GPI = DR c/o Thomas Soon
JLN BK 4/1L
Bandar Kinrara
Kuala Lumpur, Malaysia
FEI# 3003496539
All prescription drugs Medicall (Max Schmidt) 3/5/02
GPI -DR P.O. Box 373
Rhodes, Greece
FEI# 3003594531
All prescription drug HealthCarePharma (Sirirat Maihom) 3/5/02
GPI - DR 188/122 Saladang Road
Chumphorn, Thailand
FEI# 3003594528
All prescription drugs Mr. Juan Martinez (Minitraders) 3/5/02
GPI - DR P.O. Box N-121
Nassau, Bahamas
FEI# 3003594525
All prescription drugs Winedirect.net (Mr. Jorge Galet) 3/5/02
GPI -DR Gomez Becerra 18 11d
Caceres, Spain
FEI# 3003594524
All prescription drugs Cipro Antibiotics Network (D Manager) 3/5/02
GPI - DR 41 Cedar Avenue, Cedar House
Hamilton, New Zealand
FEI# 3003594522
All prescription drugs Hunter Pharmacy 6/24/02
GPI - DR 3019 Tecumseh St. E.
Windsor, Canada N8W1G8
FEI #3001597917
Medislim-brand herbal Inter Medical Lab 1/27/03
& diet pills (dba Inter Medical Clinic)
54----- 2416 Phrahonyothin Road
Lardyao, Jatujak
Bangkok, 10210 Thailand
FEI #3003141248
Recombinant Human Anhui Anke Biotechnology Co., Inc. 2/12/03
Growth Hormone Anke Bio Building
64R 18 669 Changjiang Road West
Hefei, Anhui 230088
China
FEI #3003459721
Recombinant Human Jiangxi Chinabase Import 2/12/03
Growth Hormone & Export Co., Inc.
Block C, 6/F Taoyuan Building
Taoyuan Street
Nanchang 33009
China
FEI# 3003459730
"Hemo-Olan" Olan-Kemed Co. Ltd. 2/13/03
Injectable Strychnine 176/1 Ladprano Road
Hydrochloride and Bangkok, Thailand
all other strychnine FEI# 3003099187
injectable products &
Pa Yang (and other individuals)
P.O. Box 23
Phukhae, Saraburi 18420 Thailand
FEI# 3003711523
Kamagra (Sildenafil Ajanta Pharma Limited India
100 mg. oral tablet) 318 Linking Road 4/4/03
65PD[]02 Mumbai, India
FEI# 1000446587
All prescription drugs Durus Pharma Bahamas
GPI=DR 4 Peel Street 4/22/03
Freeport, Grand Bahama Island
Bahamas
FEI# 3003755639
and
All prescription drugs Universal Trading
GPI=DR Harbor Building, Suite 6-1
Freeport, Grand Bahama Island
Bahamas
FEI# 3003716089
Sildenafil Citrate Optimum Compounding Pharmacy 4/22/03
50 mg. oral 10171 Yonge Street
(sublingual route of Richmond Hill, Ontario, Canada
administration) FEI# 3003764315
66B[][]99
65P[][]02
Zenegra RX Mexcom SA DE CV Mexico
(Sildenafil Citrate Av Lazaro Cardenas No. 4207 8/20/03
100 mg. oral tablets) Monterrey, Mexico
65PD[]02 FEI# 3004050224
GenLei Jintropin GeneScience Pharmaceuticals Co. China
Somatropin rDNA origin 72 Tianhe St. 9/4/03
human growth hormone Changchun High-Tech Development
64RCP18 Zone
Jilin Province
Changchun City, China 130012
FEI# 3003419144
Genheal (somatropin rDNA) Shanghai United Cell Bio- China
64R[][]18 technology Co., Inc.
1150 Gui Qiao Road
Pudong New Area
Shanghai, China
FEI# 3004067186
SHIPPER:
Shanghai Shang-Amer Trading Co., Ltd.
666 Zhong Shan Xi Road, Rm. 1605
Shanghai, China
FEI# 3003723654
All Finished Dosage Cipla Ltd. India
Prescription Drugs Mumbai Central 02/2/05
Not Covered by an Mumbai 400 008 India
Approved NDA FEI# 3003699941
All Finished Dosage One World Pharma Pvt. Ltd. India
Prescription Drugs 201/202/203 Second Floor 02/2/05
Ark Ind. Estate
Makwana Road, Marol
Andheri (E)
Mumbai 400 059 India
FEI# 3004467232
Reason for revision: ^
^ receives prescriptions from USA
patients, coordinates information regarding procuring prescription drugs and
fills the prescriptions with unapproved finished dosage prescription drugs
purchased from the above two firms.
Eriyos Pocket Strips Joui Limited Hong Kong
66S[][]51 Room 1402 Lap Fai Bldg 8/2/05
6-8 Pottinger St.
Hong Kong
FEI 3005045692
All Prescription Drugs Dr. B.A. Prasanna INDIA
225 10 Main, 4th Cross 11/3/05
Bangalore, India
FEI# 3004485750
All Prescription Drugs Wicks Pharmaceuticals (PVT) Ltd. INDIA
No. 1676, 2nd Cross 11/3/05
Brinivasa Colony
Mission Road
Bangalore, India
FEI# 3004407984
All Prescription Drugs Vinay Medical Stores INDIA
Raja Delux Complex 11/3/05
Nyderabad, India
FEI# 3004485731
All Prescription Drugs Meridian Marketing Services INDIA
No. 1676, 2nd Cross 11/3/05
Brinivasa Colony
Mission Road
Bangalore, India
FEI# 3004415573
Product: Source: Country:
Tadalafil Tablets Unicure Remedies Pvt. Ltd. India
66S[][]51 F-25 Industrial Estate 05/17/06
Baroda, India
FEI#3004730446
Shipper Often Declared
As Manufacturer:
AOG Offshore
P.O. Box 111717
Dubai, United Arab Emirates
FEI# 3005631066
All prescription Canada Drugs Canada
drugs 24 Terracon Place,
GPI=DR Winnipeg, Canada R2J4G7
8/25/06 FEI #3003985407
Sameday (Canada Drugs)
225 Haggart Avenue
Winnipeg, Canada R2R2V8
FEI #3005742234
Sameday (Day & Ross)
225 Haggart Avenue
Winnipeg, Canada R2R2V8
FEI #3005743984
Since May 30, 2006, Customs Border Patrol detained approximately 75 entries
of imported prescription drugs invoiced as "med supply" consigned to
individuals in the U.S. from the above three shippers. It was determined
that the drugs were worth much more than their invoiced value of $1. These
drugs are foreign manufactured and are not FDA approved for sale in the U.S.
CDER is not aware of any substantial scientific evidence that these drugs are
generally recognized as safe and effective for the conditions recommended in
their labeling.
PRODUCT SOURCE COUNTRY
ALL PRESCRIPTION ALL SOURCES ALL
DRUGS (Finished Consigned to: 10/16/06
Dosage Form) SAMSON MEDICAL TECHNOLOGIES, INC.
GPI = DR 2050 SPRINDALE ROAD
GPI = AB CHERRY HILL, NJ 08003
FEI: 3003385359 Changed Note
6/5/07
Note: On December 1, 2005, a Warning Letter was issued to Samson Medical
Technologies for importing and marketing unapproved antibiotic drug products.
The products may be offered for entry labeled as "sterile bulk" and "For
pharmacy compounding only", although the articles are in fact finished
pharmaceuticals. Currently Samson does not hold approved applications for all
these products. Districts should contact CDER Import-Export Team if they have
any questions about the regulatory status of the products.
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