Year 2008 2007 2006 2005 2004 2003 2002
U.S. Food & Drug Administration Actions: Recalls and Field Corrections Dietary Supplements -- 1/1/2007 to 12/31/2007
- Your Life Daily Pak Maximum Multivitamin-30 Days.
- Sunburst CHOLESTRIX Red Rice Yeast Extract.
- Metaboslim All Natural Fat Eater Apple Cider Vinegar Dietary Supplement.
- Pure Encapsulations Vitamin B12 Liquid.
- Pathmark Diabetic Nutritional Shake and Pathmark Pediatric Drink.
- Calcium Chews, Chocolate Flavored.
- Cocaine The Legal Alternative Energy Supplement, Free Cocaine The Legal Alternative Energy Supplement, and Cut Cocaine The Legal Alternative Energy Supplement.
- be Powered Protein Bars.
- Long Weekend, Natural Libido Enhancer.
- H S Joy of Love Sexual Energizer 100% Pure Herbal Extract 500mg/Cap.
- Lynae Shark Cartilage 750mg Capsules.
- Shark Cartilage Capsules, 740 mg, packaged & distributed under private labels (divisions of NBTY).
- Sentinel Shark Cartilage 750mg.
- Adult Multivitamins with Selenium.
- Panax Red Ginseng.
- V.MAX Herbal Stamina Enhancer for Men Dietary Supplement.
- FiberChoice plus Multivitamins Fiber Supplement chewable tablets.
- RHINO V.MAX (also labeled as RHINO V.MAX), Energy Enhancer Dietary Supplement
- MULTIVITAMINS, THER W-MINERALS TABLET; MULTIVITAMINS, THERAPEUTIC TABLET; OYSTER SHELL 500MG TABLET
- LIVIRO3 Natural Energy Enhancer Nutritional Supplement
- LEVIROL Sexual Performance Formula Dietary Supplement
- Various Vitamins and Minerals (Heartland Repack)
- Meijer brand Natural Calcium with Vitamin D USP tablets
- Diabeticine Dietary Supplement Blood Product Support, Ortho-Molecular Blend, 60 capsules
- Pedia Sure with Fiber and FOS, enteral formula, Vanilla Flavor
- Avian-Rx™ tablets, Hi-Tech Pharmaceuticals * Dietary Supplement * Bullet Proof Your Immune System * 45 tablets 500mg
- Garden Greens GojiSplash Goji Berry juice drink active polysaccharide, Super antioxidants
- NASUTRA Herbal Supplement for Men
- Neophase Natural Sex Enhancer formula for MEN Herbal Supplement
- Genesis Today Goji 100 Liquid Dietary Supplement 4 oz. and 32 oz. bottles
December 26, 2007
PRODUCT |
Your Life Daily Pak Maximum Multivitamin-30 Days, SKU#: 074970016804, UPC#: 74970016804, LHP Part #: 6B1680L, Recall # F-081-8
|
CODE |
Lot Number: 7ED0395
|
RECALLING FIRM/MANUFACTURER |
Recalling Firm: Leiner Health Products LLC, Carson, CA, by letters dated October 25, 2007.
Manufacturer: Leiner Health Products LLC, Garden Grove, CA. Firm initiated recall is ongoing.
|
REASON |
Product lot was incorrectly packaged with one instead of two Vitamin C caplets in each packet.
|
VOLUME OF PRODUCT IN COMMERCE |
11,982 units |
DISTRIBUTION |
Nationwide
|
Back to Top
November 7, 2007
PRODUCT |
Sunburst CHOLESTRIX Red Rice Yeast Extract, Standardized to contain 1.35% Lovastatin, A Dietary Supplement, 90 Vegetable Capsules, Product #489 90. UPC 6 40313 48901 9, Recall # D- D-033-2008
|
CODE |
Lot 5142 (exp. 8/11)
|
RECALLING FIRM/MANUFACTURER |
Recalling Firm: Sunburst Biorganics Inc., Baldwin, NY, by telephone on August 14, 2007.
Manufacturer: Bactolac Pharmaceutical, Inc., Hauppauge, NY. Firm initiated recall is ongoing.
|
REASON |
Unapproved new drug marketed without an approved NDA/ANDA containing Lovastatin, the active pharmaceutical ingredient in Mevacor.
|
VOLUME OF PRODUCT IN COMMERCE |
488 bottles (90 capsules per bottle)
|
DISTRIBUTION |
Nationwide
|
Back to Top
October 31, 2007
PRODUCT |
Metaboslim All Natural Fat Eater Apple Cider Vinegar Dietary Supplement, 60-capsule bottles, UPC 92483 00102, Confidence USA, Recall # D-012-2008
|
CODE |
Lot 3001006, exp. 102009
|
RECALLING FIRM/MANUFACTURER |
Recalling Firm: Confidence Inc., Port Washington, NY, by press release on August 17, 2007 and by letters on August 20 and 21, 2007.
Manufacturer: Island Vitamins Inc. Farmingdale, NY. Firm initiated recall is ongoing.
|
REASON |
Product was found to contain undeclared sibutramine, an active pharmaceutical ingredient used for weight loss in treatment of obesity.
|
VOLUME OF PRODUCT IN COMMERCE |
4,180 bottles |
DISTRIBUTION |
Canada
|
Back to Top
September 26, 2007
PRODUCT |
Pure Encapsulations Vitamin B12 Liquid, hypo-allergenic dietary supplement, Amber 30 ml (1 oz) bottle with a dropper UPC 7 6629800937 7, Recall # F-521-7
|
CODE |
Lot number: 4450707 Best by Date 07/2008
|
RECALLING FIRM/MANUFACTURER |
Recalling Firm: Pure Encapsulation, Inc., Sudbury, MA, by telephone on August 7, 2007 and follow-up letter on August 9, 2007.
Manufacturer: Atrium Innovations, Inc., Quebec, Canada. Firm initiated recall is ongoing.
|
REASON |
Product may be contaminated with mold.
|
VOLUME OF PRODUCT IN COMMERCE |
501 X 30 ml bottles |
DISTRIBUTION |
Nationwide
|
Back to Top
September 19, 2007
PRODUCT |
Unit box: Pathmark Diabetic Nutritional Shake, balanced nutrition for diabetics, strawberry, Naturally and Artificially flavored. The product is packaged in a carton containing 6 cans, 8 fl oz. each can.
Carton: Pathmark Pediatric Drink, strawberry balanced nutrition, Naturally and Artificially flavored. The product is sold in 8 fl. oz. cans, 6 cans per carton, UPC # 0-41240-20021, Recall # F-512-7
|
CODE |
MAR1808 04S/ CT 267 XX:XX. This CODE is located on the box and can. UnCODEd boxes are also included.
|
RECALLING FIRM/MANUFACTURER |
Recalling Firm: Pathmark Stores, Inc., Carteret, NJ, by e-mail and telephone on August 1, 2007.
Manufacturer: O-AT-KA Milk Products Cooperative, Inc., Batavia, NY. Firm initiated recall is ongoing.
|
REASON |
Cartons labeled Diabetic Nutritional Shake contained another product, Pediatric Drink.
|
VOLUME OF PRODUCT IN COMMERCE |
3,120 cans (130 trays)
|
DISTRIBUTION |
NY, NJ, PA, and DE
|
Back to Top
September 19, 2007
PRODUCT |
Calcium Chews, Chocolate Flavored, Containing 500 mg Calcium, 100 IU Vitamin D, 400 mcg Vitamin K, Dietary Supplement under the Albertsons, Brooks, McKesson, Meijer, Rite Aid, Topco and Walgreen's Labels, Packed 60 chews to each canister, Recall # F-514-7
|
CODE |
Lot Numbers: H0607, H0607A, H0607B, H0617, H0967
|
RECALLING FIRM/MANUFACTURER |
NutraMax Products Inc., Gloucester, MA, by letter dated May 31, 2007. Firm initiated recall is ongoing.
|
REASON |
Product contains undeclared soy lecithin.
|
VOLUME OF PRODUCT IN COMMERCE |
4,887 cases X 12 canisters per case |
DISTRIBUTION |
Nationwide
|
Back to Top
September 5, 2007
PRODUCT |
a) Cocaine The Legal Alternative Energy Supplement, 8.4 FL OZ aluminum cans, UPC code: 689076418843, Recall # D-959-2007;
b) Free Cocaine The Legal Alternative Energy Supplement, 8.4 FL OZ aluminum
cans, UPC code #689076419048, Recall # D-960-2007;
c) Cut Cocaine The Legal Alternative Energy Supplement; 8.4 FL OZ aluminum
cans, UPC code #689076418942, Recall # D-961-2007
|
CODE |
All
|
RECALLING FIRM/MANUFACTURER |
Recalling Firm: Redux Beverages, LLC, Murrieta, CA, by letter and telephone on May 7, 2007.
Manufacturer: Gluek Brewing Co., Cold Springs, MN. Firm initiated recall is ongoing.
|
REASON |
Unapproved New Drug; product's name and certain claims rendered the product an unapproved new drug.
|
VOLUME OF PRODUCT IN COMMERCE |
Approximately 100,416 cases/24 cans per case |
DISTRIBUTION |
Nationwide and Internationally
|
Back to Top
September 5, 2007
PRODUCT |
a) be Powered Protein Bar all natural chocolate raspberry,
be Powered Protein Bar all natural chocolate raspberry ,
4 bars 2.0 oz (57 g) total net wt 8.0 oz (227g); Supports peak energy,
heart-healthy protein for a leaner body, helps support healthy immune
function, Recall # F-496-7;
b) be Powered Protein Bar all natural wild berry, be Powered Protein Bar
all natural wild berry , 4 bars 2.0 oz (57 g) total net wt 8.0 oz (227g);
Supports peak energy, heart-healthy protein for a leaner body, helps
support healthy immune function, Recall # F- F-497-7;
c) be Healthy Kids Snack Bar all natural peanut butter, 5 bars 1.5 oz (43 g)
total net wt 7.5 oz (215g); low fat, whole grain, high energy, perfect snack
for after school, practice or anytime, healthy eating for healthy kids,
Recall # F-498-7;
d) be Healthy Kids Snack Bar all natural chocolate chip, 5 bars 1.5 oz (43 g)
total net wt 7.5 oz (215g); low fat, whole grain, high energy, perfect snack
for after school, practice or anytime, healthy eating for healthy kids,
Recall # F-499-7
|
CODE |
a) 1-85337-00030-2 single 1-85337-00080-7 4pk 1-85337-09080-8 4 pk+2 bonus;
b) 1-85337-00031-9 single 1-85337-00081-4 4pk 1-85337-09081-5 4pk+ 2 bonus;
c) 1-85337-00251-1 5pk;
d) 1-85337-00250-4 5pk
|
RECALLING FIRM/MANUFACTURER |
Recalling Firm: Be unlimited, Ltd, Milwaukee, WI, by telephone, on June 1, 2007.
Manufacturer: Colorado Baking Company, Colorado Springs, CO. Firm initiated recall is ongoing.
|
REASON |
Manufacturing issue has been identified that results in the potential for these products to develop mold prior to their expiration date.
|
VOLUME OF PRODUCT IN COMMERCE |
430,200 bars |
DISTRIBUTION |
MN
|
Back to Top
August 22, 2007
PRODUCT |
Long Weekend, Natural Libido Enhancer, (Epimedium P.E. 300 mg, Fructus Lycii P. E. 50 mg), A Dietary Supplement, 3 capsules/box, UPC 809515-0542, Recall # D-951-2007
|
CODE |
All lots
|
RECALLING FIRM/MANUFACTURER |
Confidence, Inc., Port Washington, NY, by telephone on June 6, 2007 and by press release on June 14, 2007. Firm initiated recall is ongoing.
|
REASON |
Unapproved new drug; product was found to contain undeclared tadalafil, the active pharmaceutical ingredient in an FDA-approved drug used to treat erectile dysfunction.
|
VOLUME OF PRODUCT IN COMMERCE |
Approximately 4,772 capsules
|
DISTRIBUTION |
Nationwide, Canada, UK, Russia, Spain and China
|
Back to Top
August 15, 2007
PRODUCT |
H S Joy of Love Sexual Energizer 100% Pure Herbal Extract 500mg/Cap, 12 Caps/box, Recall # D-942-2007
|
CODE |
''USEBY 09-05-09 LOT # I-05-06-2''
|
RECALLING FIRM/MANUFACTURER |
Recalling Firm: Jen-On Herbal Science International Inc., City of Industry, CA, by telephone on April 12, 2007, press release on April 17, 2007 and by letter on April 18, 2007.
Manufacturer: Herbal Science International, Inc., Walnut, CA. Firm initiated recall is ongoing.
|
REASON |
Unapproved New Drug. Product has been found to contain piperadino vardenafil, an analogue of Vardenafil, an FDA-approved drug used to treat Erectile Dysfunction (ED).
|
VOLUME OF PRODUCT IN COMMERCE |
2,484 boxes |
DISTRIBUTION |
CA, CO, FL, NV, TX, WA, NJ, IL, MA
|
Back to Top
August 15, 2007
PRODUCT |
Lynae Shark Cartilage 750mg Capsules, Product Number FS1001, Lot Number FJ04101F, Expiration Date 12/2008, UPC Number 85714 00282 2, 100 capsules per bottle, Recall # Recall # F-465-7
|
CODE |
Lot Number FJ04101F, Expiration Date 12/2008
|
RECALLING FIRM/MANUFACTURER |
Recalling Firm: Boscogen Inc., Irvine, CA, by telephone on June 11, 2007, e-mails on June 12, 2007 and letters on June 13, 2007.
Manufacturer: NBTY Inc., Bohemia, NY. Firm initiated recall is complete.
|
REASON |
Testing performed recently by the manufacturer, shows that the recalled capsules have the potential to be contaminated with Salmonella.
|
VOLUME OF PRODUCT IN COMMERCE |
487 bottles of 100 capsules each |
DISTRIBUTION |
CA, Canada, Romania, Switzerland, Thailand, The Netherlands and Vietnam
|
Back to Top
August 8, 2007
PRODUCT |
Shark Cartilage Capsules, 740 mg, packaged & distributed under the following private labels (divisions of NBTY):
(1) Puritan's Pride brand Shark Cartilage Capsules, Product No. 6580, 100 Capsule Size, UPC 74312 16580 1;
(2) Good 'N Natural brand Shark Cartilage Capsules, Product No. 6580, 100 Capsules, UPC 74312 46580 2;
(3) Nature's Bounty brand Shark Cartilage Capsules, Product No. 6581, 30 Capsules + 30 Free Size, UPC 74312 06581 1;
(4) Natural Wealth brand Shark Cartilage Capsules, Product No. 6581, 30 Capsules, UPC 74312 86581 1;
(5) Physiologics brand Shark Cartilage Capsules, Product No. 55131, 100 Capsules, UPC 16963 55131 1;
(6) Rexall Sundown brand Shark Cartilage Capsules, Product No. 6635, 50 Capsules, UPC 30768 06635 2, and Product No. 44605, 50 capsules, UPC 30768 51150;
(7) Vitamin World brand Shark Cartilage Capsules, Product No. 6580, 100 Capsule Size, UPC 74312 76580 3; Product No. 6582, 200 Capsule Size, UPC 74312 76582 7; Product No. 6585, 400 Capsule Size, UPC 74312 76585 8, Recall # F-462-7
|
CODE |
(1) Lots 64950 (expiration date 8/08), 64951 (expiration date 9/08), and 66293 (expiration date 10/08);
(2) Lot 64951 (expiration date 9/08);
(3) Lots 64950 (expiration date 8/08), 64951 (expiration date 9/08), and 66293 (expiration date 10/08);
(4) Lot No. 64950 (expiration date 8/08);
(5) Lot No. 64951, expiration date 9/08;
(6) Lots 64951 (expiration date 9/08) and 66293 (expiration date 10/08); Lot 64951 (expiration date 9/08);
(7) Lots 64950 (expiration date 8/08), 64951 (expiration date 9/08), and 66293 (expiration date 10/08).
|
RECALLING FIRM/MANUFACTURER |
NTBY, Inc., Bohemia, NY, by a nationwide press release on May 16, 2007, letters dated May 17, 2007 and June 1, 2007 and e-mail on May 23, 2007. Firm initiated recall is ongoing.
|
REASON |
Shark Cartilage Capsules may be contaminated with Salmonella.
|
VOLUME OF PRODUCT IN COMMERCE |
8,784,710 capsules |
DISTRIBUTION |
Nationwide and Internationally
|
Back to Top
August 1, 2007
PRODUCT |
Sentinel Shark Cartilage 750mg, UPC 28245 00313 6, Recall # F-449-7
|
CODE |
Lot number 064951, expiration date 07 2009
|
RECALLING FIRM/MANUFACTURER |
Recalling Firm: Action Labs, Inc., Anaheim, CA, by letters starting on May 23, 2007 and by press release on June 6, 2007.
Manufacturer: NBTY Inc., Bohemia, NY. Firm initiated recall is complete.
|
REASON |
Testing performed recently at NBTY, Inc. (the manufacturer) shows that the recalled capsules have the potential to be contaminated with Salmonella.
|
VOLUME OF PRODUCT IN COMMERCE |
1190 bottles of 60 capsules each |
DISTRIBUTION |
CA and Hong Kong
|
Back to Top
July 25, 2007
PRODUCT |
Adult Multivitamins with Selenium, 1000 tablets/bottle; NDC #51376-0180-10, Recall # F-445-7
|
CODE |
Lot #704064
|
RECALLING FIRM/MANUFACTURER |
Recalling Firm: Blessings International, Tulsa, OK, by e-mail on June 26, 2007.
Manufacturer: Rasi Laboratories, Inc., Somerset, NJ. Firm initiated recall is ongoing.
|
REASON |
Product was mislabeled in that it contained iron and iodine, which were not listed.
|
VOLUME OF PRODUCT IN COMMERCE |
188 bottles |
DISTRIBUTION |
Nationwide and Internationally
|
Back to Top
July 18, 2007
PRODUCT |
Panax Red Ginseng, One Pound, Grade 15, 'Heven' Label on the tin states: Panax Red Ginseng Net Wt : 16oz (450g) Product of China, Recall # F-436-7
|
CODE |
No codes available on the product. However the package (tin) shows letter 'A', the number '15' and a Chinese symbol which means 'Heaven'.
|
RECALLING FIRM/MANUFACTURER |
Recalling Firm: Kwok Shing Inc., San Francisco, CA, by letter and telephone on May 24, 2006.
Manufacturer: Gosheng Industrial (Shenzhen) Co LTD, Shenzhen, China. Firm initiated recall is ongoing.
|
REASON |
FDA analysis found the following pesticide residues which are not allowed for use in ginseng: quintozene (PCNB), pentachlorophenyl methyl sulfide, pentachloroaniline, alpha-BHC, 2,3,5,6 tetrachloroaniline, hexachlorobenzene and pentachlorobenzene.
|
VOLUME OF PRODUCT IN COMMERCE |
600 pounds |
DISTRIBUTION |
CA and OR
|
Back to Top
July 11, 2007
PRODUCT |
V.MAX Herbal Stamina Enhancer for Men Dietary Supplement, Cordyceps Militaries, L-Arginine, Psyllium Husk Powder, Licorice Root, Astragalus Membranaceus, Steamed Panax Ginseng, Zinc Oxide, 0.5g, 15 Capsules cartons, Recall # D-830-2007
|
CODE |
VM0501 |
RECALLING FIRM/MANUFACTURER |
Recalling Firm: Barodon S.F., Inc., Los Angeles, CA, by visits in December 2006 and by press release on March 16, 2007.
Manufacturer: MegaCare Inc., Las Vegas, NV, Firm initiated recall is ongoing.
|
REASON |
Unapproved New Drug - product has been found to contain Aminotadalafil an analogue of tadalafil, a drug used to treat erectile dysfunction.
|
VOLUME OF PRODUCT IN COMMERCE |
200,000 capsules |
DISTRIBUTION |
Nationwide, South Korea and Japan
|
Back to Top
July 11, 2007
PRODUCT |
FiberChoice plus Multivitamins Fiber Supplement chewable tablets. Contains
Insulin fiber (2g per tablet) along with 13 essential vitamins and minerals. 90
count plastic bottles, (16 oz.), UPC#5714500581, Recall # F-432-7 |
CODE |
Lot numbers: 06L062, 06L063,06L102, 06M075, 07A001,07A002, 07A003,07A004,07A005,
07A006, 07A007, 07A008, 07A009,
07A051,07A052,07A053,07A054,07A055,07A068,07A069, 07A070,07A072,
07A073,07A074,07A075,07A076,07A077,07A078,07A080, 07A116, 07A117,07A118, 07A119,
07A120 87673901 (display) |
RECALLING FIRM/MANUFACTURER |
Recalling Firm: Glaxo Smith Kline, Parsippany, NJ, by press release on March 20, 2007 and by letter on March 21, 2007.
Manufacturer: Amerilab Technologies, Inc., Plymouth, MN. Firm initiated recall is ongoing. |
REASON |
GSK purchased CNS Inc, the marketer of the Fiber Choice Fiber Supplement line of
products, on 12/19/2006. During a review of all formulation and manufacturing
procedures, it was discovered that the Vitamin A use in FiberChoice with
Multivitamins Fiber Supplement contains undeclared fish gelatin in the raw
material. |
VOLUME OF PRODUCT IN COMMERCE |
145,134 bottles |
DISTRIBUTION |
Nationwide |
Back to Top
June 27, 2007
PRODUCT |
RHINO V MAX (also labeled as RHINO V.MAX), Energy Enhancer Dietary Supplement, 5
and 15 capsules blister pack cartons, Recall # D-817-2007 |
CODE |
N/A |
RECALLING FIRM/MANUFACTURER |
Recalling Firm: Cosmos Trading, Los Angeles, CA, by telephone, fax and letter on March 12, 2007, and by press release on March 16, 2007.
Manufacturer: MegaCare, Inc., Las Vegas, NV. Firm initiated recall is ongoing. |
REASON |
Unapproved New Drug; Product found to contain Aminotadalafil an analogue of
tadalafil, a drug product to treat erectile dysfunction. |
VOLUME OF PRODUCT IN COMMERCE |
4,976 retail units
|
DISTRIBUTION |
CA and NV |
Back to Top
May 30, 2007
PRODUCT |
Part of a larger recall:
jjj) MULTIVITAMINS, THER W-MINERALS TABLET, 250 count bags
(NDC #61392035125) & 30 count boxes (NDC #61392035130), OTC,
Recall # D-637-2007;
kkk) MULTIVITAMINS, THERAPEUTIC TABLET, 250 count bags (NDC #61392035025)
& 30 count boxes (NDC #61392035030), OTC, Recall # D-638-2007;
zzz) OYSTER SHELL 500MG TABLET, 250 count bags (NDC #61392000625),
30 count bingo card (NDC #61392000639), 30 count boxes (NDC #61392000630)
& 60 count boxes (NDC #61392000660), OTC, Recall # D-653-2007; |
CODE |
jjj) All Lot Codes: U36931A25, U37528B25, U38395C25, U39804A25, U40236A25,
U40436B25, U40436C25, U40628B25, U40628C25, U41021A25, U41440A25,
U43047a25, C43469B25, C42753B25, C43675B25, C43675E25, U36186A30,
U36931B30, U37528A30, U37845A30, U38395A30, U38395B30, U38395E30,
U38395D30, U38893A30, U37528C30, U37528D30, U39804B30, U37528E30,
U37528F30, U40236C30, U40236B30, U40436A30, U40436D30, U40628A30,
U40628D30, U41021B30, U41440B30, U42002A30, U42671A30, U43047B30,
C43469A30, C42753A30, C43675C30, C43675D30;
kkk) All Lot Codes: U36448A25, U36448D25, U37144A25, U37144B25, U38483A25,
U40287A25, U40990A25, U41274A25, U41994A25, C42793B25, U42666A25,
U36471B30, U36471A30, U36448C30, U36448B30, U37144C30, U37593A30,
U37144D30, U38483B30, U38483C30, U37905A30, U38986A30, U39986A30,
U40127A30, U40990B30, U41274B30, U41994B30, C42793A30, C42793C30,
U42666B30, C43230A30, U42995A30, C43230B30;
zzz) All Lot Codes: U36507B25, U36922B25, U37139B25, U39260A25,
U37139E25, U36922D25, U40314A25, U40314D25, U40953A25,
U42672A25, 36457, 006E0508, 006F0513, 006G0507, 006H0509,
006j0504, 006J0516, 006K0517, 39009, 006L0532, 006M0517, 006A0624,
006A0627, 066B0615, 006D0602, 006E0603, 006F0633, 006E0602, 43204,
U36507A30, U36922A30, U36242B30, U36922C30, U37139C30, U38852A30,
U39260B30, U39022A30, U38147A30, U37882C30, U38852B30, U40000A30,
U39803B30, U40000B30, U40314B30, U40314E30, U40953C30, U43268B30,
U36242A60, U37139A60, U37139D60, U37882A60, U37882B60, U39803A60,
U40314C60, U40953B60, U41563A60, U41941A60, U41630A60, U42672B60,
U43268A60 |
RECALLING FIRM/MANUFACTURER |
Heartland Repack Services, LLC, Toledo, OH, by telephone between February 14, 2007 and February 20, 2007. Firm initiated recall is ongoing. |
REASON |
Misbranding. There is the possibility of multiple product packaging mix-ups. An
OTC drug, Rx drug ,or nutritional supplement other than what is indicated on the
product labeling, may be inside the packaging. |
VOLUME OF PRODUCT IN COMMERCE |
566,734,636 units |
DISTRIBUTION |
Nationwide |
Back to Top
May 23, 2007
PRODUCT |
LIVIRO3 Natural Energy Enhancer Nutritional Supplement, 450mg Capsules, packaged
in boxes of 10 capsules and bottles of 20 capsules, Recall # D-796-2007 |
CODE |
The firm indicated the distributed 5 lots(#1-5) Lot#1 Exp. Date 03/2006, Lot#2
Exp. Date 11/2008, Lot#3 Exp. Date 0/2009, Lot#4 Exp. Date 07/2009 & Lot#5 Exp. Date 07/2009 NOTE: THIS IS WHAT WAS FOUND ON SAMPLE COLLECTED- Underneath the aluminum try that contains all 10 capsules of LIVIRO3 (found inside box), there are lot codes and expiration dated imprinted on it. The lot code for the FDA sample is LOT 0730 EXP 07/30/2009. There might be other lot codes since it appears that the lot code correspond with the expiration date. Note: Other codes pending |
RECALLING FIRM/MANUFACTURER |
Recalling Firm: Ebek, Inc, Los Angeles, CA, by telephone on January 10, 2007, press release on January 19, 2007 and January 29, 2007, and by letters beginning January 29, 2007.
Manufacturer: West Coast Laboratories Inc, Gardena, CA. Firm initiated recall is ongoing. |
REASON |
Unapproved New Drug; product to contain the undeclared ingredient Tadalafil, the
active pharmaceutical ingredient in an FDA approved drug used to treat erectile
dysfunction. |
VOLUME OF PRODUCT IN COMMERCE |
278,260 capsules |
DISTRIBUTION |
Nationwide |
Back to Top
May 23, 2007
PRODUCT |
LEVIROL Sexual Performance Formula Dietary Supplement, a proprietary blend of:
Epimedium (Epimedium sagittatum leaf), 2 Capsules per pack, Recall #
D-795-2007 |
CODE |
Lot # 0606332 expires 06/09 & Lot # 0605143 expires 05/09 |
RECALLING FIRM/MANUFACTURER |
Recalling Firm: Levirol, LLC, Tempe, AZ, by letter on January 28, 2007, and February 12, 2007.
Manufacturer: Bactolac Pharmaceutical, Inc, Hauppauge, NY. Firm initiated recall is ongoing. |
REASON |
Unapproved New Drug; product found to contain the undeclared ingredient
Aminotadalafil, an analogue of Tadalafil, the active pharmaceutical ingredient
found in an FDA approved drug used for erectile dysfunction. |
VOLUME OF PRODUCT IN COMMERCE |
22,658 capsules (11,329 x2 capsule packages) |
DISTRIBUTION |
Nationwide and Canada |
Back to Top
May 16, 2007
PRODUCT |
a) FERROUS GLUCONATE 324MG TABLET, 250 count bags (NDC #61392022625),
30 count bingo card (NDC #61392022639) & 30 count box (NDC #61392022630),
OTC, Recall # F-242-7;
b) FERROUS SULFATE 325MG TABLET GREEN, 250 count bags
(NDC #61392012725), 30 count bingo card (NDC #61392012739),
30 count boxes (NDC #61392012730), 60 count boxes (NDC #61392012760)
& 90 count boxes (NDC #61392012790), OTC, F-243-7;
c) ONE TAB DAILY TABLET, 250 count bags (NDC #61392093825) &
30 count boxes (NDC #61392093830), OTC, Recall # F-244-7;
d) ONE TAB DAILY W/ IRON TABLET, 250 count bags (NDC #61392001525)
& 30 count boxes (NDC #61392001530), OTC, Recall # F-245-7;
e) OYSTER SHELL 500MG TABLET, 250 count bags (NDC #61392000625),
30 count bingo card (NDC #61392000639), 30 count boxes (NDC #61392000630)
& 60 count boxes (NDC #61392000660), OTC, Recall # F-246-7;
f) VITAMIN B1 (THIAMINE) 50MG TABLET, 30 count bingo card (NDC #61392050639),
OTC, Recall # F-247-7;
g) VITAMIN B12 1000MCG TABLET, 30 count bingo card (NDC #61392057539), OTC,
Recall # F-248-7;
h) VITAMIN B12 100MCG TABLET, 30 count bingo card (NDC #61392050239)
& 30 count boxes (NDC #61392050230), OTC, Recall # 249-7;
i) VITAMIN B12 500MCG TABLET, 250 count bags (NDC #61392050325),
30 count bingo card (NDC #61392050339) & 30 count boxes (NDC #61392050330),
OTC, Recall # F-250-7;
j) VITAMIN C 250MG TABLET (ASCORBIC ACID), 250 count bags
(NDC #61392015525), 30 count bingo card (NDC #61392015539),
30 count boxes (NDC #61392015530), OTC, Recall # F-251-7;
k) CALCIUM CARBONATE W/D 600MG TABLET, Recall # F-252-7;
l) CALCIUM W/D 250MG/125IU TABLET, 250 count bags (NDC #61392004725),
30 count bingo card (NDC #61392004739), & 30 count boxes (NDC #61392004730),
OTC, Recall # F-253-7;
m) CALCIUM W/D 500MG/200IU TABLET, 250 count bags (NDC #61392065325),
30 count bingo card (NDC #61392065339), 30 count boxes (NDC #61392065330),
60 count boxes (NDC #61392065360), OTC, Recall # F-254-7
|
CODE |
a) All Lot Codes: U39727B25, U39727C25, U41009A25, U41946B25, 226M0501,
226A0646, 226E0617, U39727A30, U41009B30, U41946A30;
b) All Lot Codes: U37269B25, U37519A25, U37519C25, U38039B25, 127D0512,
127F0513, 127G0503, 127H0503, 127j0504, U36642C30, U36781C30,
U36781D30, U36781F30, U37519B30, U38346B30, U38346C30, U38346D30,
U37519D30, U38039C30, U36642A60, U36781A60, U36781B60, U36642E60,
U36781E60, U37269A60, U37146A60, U38346A60, U38039D60, U38346E60,
U36642B90, U36642D90, U38039A90;
c) All Lot Codes: U36554B25, U36271D25, U36554C25, U37557B25, U38195B25,
U38944A25, U40237A25, U40434A25, C40481B25, U41252A25, U41252B25,
C41967B25, C42641B25, C43073B25, U36271A30, U36271B30, U36271C30,
U36554A30, U37009A30, U36779A30, U36554D30, U36554E30, U37557A30,
U37809A30, U38042A30, U38042B30, U38195A30, U38943A30, U38603A30,
U38603B30, U38944B30, C39966A30, U38943B30, U39177A30, C39966B30,
C40481, U40237B30, U40434B30, C41967A30, C41967C30, C41967D30,
U41991A30, C42641A30, C43073A30, C43310A30, C43310B30;
d) All Lot Codes: U36246A25, U37140B25, U37807B25, U38679A25, U39855B25,
U39855C25, U41174A25, U36246B30, U36246C30, U37140A30, U37807A30,
U37807C30, U38389A30, U38679B30, U37140C30, U37807D30, U38389B30,
U39855A30, U39855D30, U40601B30, U41174B30, U43046A30;
e) All Lot Codes: U36507B25, U36922B25, U37139B25, U39260A25, U37139E25,
U36922D25, U40314A25, U40314D25, U40953A25, U42672A25, 36457, 006E0508,
006F0513, 006G0507, 006H0509, 006j0504, 006J0516, 006K0517, 39009, 006L0532,
006M0517, 006A0624, 006A0627, 066B0615, 006D0602, 006E0603, 006F0633,
006E0602, 43204, U36507A30, U36922A30, U36242B30, U36922C30, U37139C30,
U38852A30, U39260B30, U39022A30, U38147A30, U37882C30, U38852B30,
U40000A30, U39803B30, U40000B30, U40314B30, U40314E30, U40953C30,
U43268B30, U36242A60, U37139A60, U37139D60, U37882A60, U37882B60,
U39803A60, U40314C60, U40953B60, U41563A60, U41941A60, U41630A60,
U42672B60, U43268A60;
f) All Lot Codes: 39157, 506M0540;
g) All Lot Codes: 37002, 37235, 37683, 37897, 575k0531, 575A0621, 41079,
41584, 575E0622
h) All Lot Codes: 39156, 39940, 41078, U41634A30;
i) All Lot Codes: U41635A25, 38459, 39458, 503A0650, 41740, 42769, U41635B30;
j) All Lot Codes: U41007B25, C42424A25, 36191, 36588, 38994, 38995,
155M0517, 155C0613, U41007A30, C42426B30, C42424A30;
k) All Lot Codes: C41644A30;
l) All Lot Codes: U39848B25, U40168A25, U40604A25, U41177B25, U41177C25,
047k0508, 047L0533, 047M0520, 047A0612, 047B0645, 047EO632, 42845,
U38439A30, U38439B30, U38439C30, U39848A30, U39848C30, U40168B30,
U40604B30, U40604C30, U41177A30, U41177D30;
m) All Lot Codes: U40264A25, U40282A25, U40282D25, U40635A25, U40112D25,
U40282E25, U40635B25, U41876A25, U42232A25, U42569A25, U42603A25,
U43214D25, 653A0606, 653A0634, 653A0652, 653B0623, 653B0628, 653D0602,
653D0628, 653F0607, 653F0640, 653E0620, 653F0608, U40112C30, U40264B30,
U40264C30, U40264E30, U40264D30, U40282B30, U40282C30, U41876C30,
U41876D30, U42232C30, U42569C30, U42568A30, U42568B30, U43214B30,
U43214A30, U43214C30, U40112B60, U40112A60, U40635C60, U40810A60,
U41876B60, U42232B60, U42568C60, U42603B60, U42569B60, U43214E60 |
RECALLING FIRM/MANUFACTURER |
Heartland Repack Services LLC, Toledo, OH, by telephone between February 14 and February 20, 2007. Firm initiated recall is ongoing. |
REASON |
Misbranding. There is the possibility of multiple product packaging mix-ups. An
OTC drug, RX drug, or nutritional supplement, other than what is indicated on
the product labeling, may be inside the packaging. |
VOLUME OF PRODUCT IN COMMERCE |
31,485,030 units= 2,140,500/250 count; 257,220/90 count; 4,043,400/60 count
& 25,043910/30 count |
DISTRIBUTION |
Nationwide |
Back to Top
April 18, 2007
PRODUCT |
Meijer brand Natural Calcium with Vitamin D USP tablets, 1200 mg & D per serving, 300 coated caplets; UPC 4125003889; Recall # F-195-7 |
CODE |
Lot: 5HN0384; Exp. 05/2009 |
RECALLING FIRM/MANUFACTURER |
Recalling Firm: L. Perrigo Co., Allegan, MI, by email on January 31, 2007.
Manufacturer: Perrigo Company of South Carolina, Greenville, SC. Firm initiated recall is ongoing. |
REASON |
The bottles may actually contain 400 IU Vitamin E gelcaps. |
VOLUME OF PRODUCT IN COMMERCE |
3,228 bottles |
DISTRIBUTION |
MI |
Back to Top
April 11, 2007
PRODUCT |
Diabeticine Dietary Supplement Blood Product Support, Ortho-Molecular Blend, 60
capsules, Dr. Theo’s Cellular Health, Recall # F-173-7 |
CODE |
All lots on the market at the time of the recall |
RECALLING FIRM/MANUFACTURER |
Techmedica Health Inc., Grand Rapids, MI., by telephone beginning on May 9, 2006 and by letters on or about May 9, 2006 and June 23, 2006. Firm initiated recall is complete. |
REASON |
The product is an unapproved new drug because the therapeutic claims on the
firm’s web site establish that the product is promoted for use in the cure, mitigation treatment or prevention of disease (diabetes). |
VOLUME OF PRODUCT IN COMMERCE |
Not available |
DISTRIBUTION |
Nationwide |
Back to Top
April 4, 2007
PRODUCT |
Pedia Sure with Fiber and FOS, enteral formula, Vanilla Flavor, Recall #
F-168-7 |
CODE |
49304RE, use by 1 Feb 2008 |
RECALLING FIRM/MANUFACTURER |
Recalling Firm: Ross Products Division Abbott Laboratories, Columbus, OH., by letter dated January 23, 2007 and by visit on January 24, 2007.
Manufacturer: Ross Products Division Abbott Laboratories, Casa Grande, AZ. Firm initiated recall is ongoing. |
REASON |
PediaSure with Fiber and FOS, Enteral Formula does not meet label claim for
micronutrients – choline and 1-carnitine. |
VOLUME OF PRODUCT IN COMMERCE |
289 cases/24/8 oz metal cans per case |
DISTRIBUTION |
AZ and CA |
Back to Top
March 28, 2007
PRODUCT |
Avian-Rx™ tablets, Hi-Tech Pharmaceuticals * Dietary Supplement * Bullet Proof Your Immune System * 45 tablets 500mg, Hi-Tech Pharmaceuticals, Inc., 5015 B Unity Drive, Norcross, GA 30871, sold over-the-counter, labeled to contain a combination of herbal ingredients for use as an immune support booster. The primary ingredients (per tablet) listed on the product's labeling include the following: star anise extract, shikimic acid, and hypericum perforatum. The product's labeling recommends a dosage of 3 tablets for 10 days, followed by 1 tablet daily; manufactured January 2006. UPC of: 8 57084 00079 8, Recall # F-158-7 |
CODE |
Lot # 06202044, expiration January 2009 |
RECALLING FIRM/MANUFACTURER |
Hi Tech Pharmaceuticals, Norcross, GA, by letter on/about May 16, 2006. Firm initiated recall is ongoing. |
REASON |
Dietary Supplement makes unapproved drug claim that it can prevent Bird Flu and
also fails to label one of its ingredients, star anise, properly. |
VOLUME OF PRODUCT IN COMMERCE |
2,331 bottles containing 45 tablets per bottle |
DISTRIBUTION |
CA, MD, SD and TX |
Back to Top
March 7, 2007
PRODUCT |
Garden Greens GojiSplash Goji Berry juice drink active polysaccharide, Super
antioxidants, helps support youth and vitality. Dietary supplement 30
servings/30 fl oz. (900 mL) plastic bottle, TC# A5821002, item N6004, UPC
3504606004, Recall # F-129-7 |
CODE |
All lots that fail to declare sulfites as an ingredient. |
RECALLING FIRM/MANUFACTURER |
Recalling Firm: Windmill, West Caldwell, NJ, by letter beginning on January 3, 2007.
Manufacturer: Celmark Hydroceuticals, Orlando, FL. Firm initiated recall is ongoing. |
REASON |
Undeclared sulfites at a level of 10.8 ppm were found during product
testing. |
VOLUME OF PRODUCT IN COMMERCE |
39,836 bottles, 30 fl oz. each |
DISTRIBUTION |
Nationwide |
Back to Top
February 14, 2007
PRODUCT |
NASUTRA Herbal Supplement for Men, proprietary blend of ten chinese herbs,
300mg, packaged in blisters of 2 capsules, Recall # D-438-7 |
CODE |
Lot #: WP-505, WP904, WP1005, WP106, WP206, WPNA5O6 & WPNA7O6 |
RECALLING FIRM/MANUFACTURER |
Recalling Firm: Nasutra LLC, Beverly Hills, CA, by letter and press release on September 20, 2006.
Manufacturer: Bactolac Pharmaceutical, Inc., Hauppauge, NY. Firm initiated recall is ongoing. |
REASON |
Unapproved New Drug; Product contains undeclared acetildenafil, an analogue of
sildenafil. |
VOLUME OF PRODUCT IN COMMERCE |
1,105,000 X 2-capsule units |
DISTRIBUTION |
Nationwide and via the Internet |
Back to Top
February 7, 2007
PRODUCT |
Neophase Natural Sex Enhancer formula for MEN Herbal Supplement, Proprietary Blend 700mg of Ginsenoside, Rhodiola crenulata root, Lysium chinesis fruit, Curculigo rhizome root, Licorice root, Snow lotus flower, Cuscuta chinesis and Cordyceps sinensis, 4 Soft capsules per bottle, Recall # D-435-2007
|
CODE |
All Codes
|
RECALLING FIRM/MANUFACTURER |
Recalling Firm: North American Distributor Group, LLC, San Francisco, CA, by e-mails and letters on July 17, 2006.
Manufacturer: Vigor Nutriceutical, Inc., Sun Prairie, WI. Firm initiated recall is complete.
|
REASON |
Unapproved New Drug; product found to contain homosildenafil, an analogue of sildenafil.
|
VOLUME OF PRODUCT IN COMMERCE |
396 bottles |
DISTRIBUTION |
CA |
Back to Top
January 10, 2007
PRODUCT |
Genesis Today Goji 100 Liquid Dietary Supplement 4 oz. and 32 oz. bottles; UPC Code 83448 00060 (4oz.) and 83448 00056 (32oz.), Recall # F-085-7
|
CODE |
Lot number: 0234F6 (4 oz.), Lot number: 0228F6 (32 oz.) and Lot number: 0273D6 (32 oz.)
|
RECALLING FIRM/MANUFACTURER |
Recalling Firm: Genesis Today, Inc., Austin, TX, by telephone on October 16, 2006. and letter on October 25, 2006.
Manufacturer: Celmark Hydroceuticals, Orlando, FL. Firm initiated recall is ongoing.
|
REASON |
Product contains undeclared Sulfites.
|
VOLUME OF PRODUCT IN COMMERCE |
17,292 bottles |
DISTRIBUTION |
FL, NC, PA, VA, and Canada |
Back to Top
|