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FDA Recalls (2007)

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U.S. Food & Drug Administration Actions: Recalls and Field Corrections Dietary Supplements -- 1/1/2007 to 12/31/2007

  1. Your Life Daily Pak Maximum Multivitamin-30 Days.
  2. Sunburst CHOLESTRIX Red Rice Yeast Extract.
  3. Metaboslim All Natural Fat Eater Apple Cider Vinegar Dietary Supplement.
  4. Pure Encapsulations Vitamin B12 Liquid.
  5. Pathmark Diabetic Nutritional Shake and Pathmark Pediatric Drink.
  6. Calcium Chews, Chocolate Flavored.
  7. Cocaine The Legal Alternative Energy Supplement, Free Cocaine The Legal Alternative Energy Supplement, and Cut Cocaine The Legal Alternative Energy Supplement.
  8. be Powered Protein Bars.
  9. Long Weekend, Natural Libido Enhancer.
  10. H S Joy of Love Sexual Energizer 100% Pure Herbal Extract 500mg/Cap.
  11. Lynae Shark Cartilage 750mg Capsules.
  12. Shark Cartilage Capsules, 740 mg, packaged & distributed under private labels (divisions of NBTY).
  13. Sentinel Shark Cartilage 750mg.
  14. Adult Multivitamins with Selenium.
  15. Panax Red Ginseng.
  16. V.MAX Herbal Stamina Enhancer for Men Dietary Supplement.
  17. FiberChoice plus Multivitamins Fiber Supplement chewable tablets.
  18. RHINO V.MAX (also labeled as RHINO V.MAX), Energy Enhancer Dietary Supplement
  19. MULTIVITAMINS, THER W-MINERALS TABLET; MULTIVITAMINS, THERAPEUTIC TABLET; OYSTER SHELL 500MG TABLET
  20. LIVIRO3 Natural Energy Enhancer Nutritional Supplement
  21. LEVIROL Sexual Performance Formula Dietary Supplement
  22. Various Vitamins and Minerals (Heartland Repack)
  23. Meijer brand Natural Calcium with Vitamin D USP tablets
  24. Diabeticine Dietary Supplement Blood Product Support, Ortho-Molecular Blend, 60 capsules
  25. Pedia Sure with Fiber and FOS, enteral formula, Vanilla Flavor
  26. Avian-Rx™ tablets, Hi-Tech Pharmaceuticals * Dietary Supplement * Bullet Proof Your Immune System * 45 tablets 500mg
  27. Garden Greens GojiSplash Goji Berry juice drink active polysaccharide, Super antioxidants
  28. NASUTRA Herbal Supplement for Men
  29. Neophase Natural Sex Enhancer formula for MEN Herbal Supplement
  30. 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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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
FDA Website: www.FDA.gov
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Last updated: 22 January 2009