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FDA Recalls (2003)

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U.S. Food & Drug Administration Actions: Recalls and Field Corrections Dietary Supplements -- 2003

  1. Biochem brand Ultimate Lo Carb Bar, Chocolate Brownie Nut
  2. Labrada Nutrition brand Lean Body Hi Protein Meal Replacement Bar - Cookies & Cream flavor
  3. Mason Natural Chewable Calcium 600 with Vitamin D
  4. Natural Treasures TMG
  5. Nature's Remedy Tablets (Sennosides, USP 8.6mg) Stimulant Laxative
  6. Nature's Remedy Tablets, (Cascara sagrada 150mg and Aloe 100mg) Laxative
  7. Re-Vita Liqua Health. Berry Flavored Dietary Supplement (2)
  8. Re-Vita Liqua Health. Butternut flavor Dietary Supplement
  9. Re-Vita Liqua Health. Grape Flavored Dietary Supplement (2)
  10. Re-Vita Liqua Health. Lemon-Lime Flavored Dietary Supplement (2)
  11. Sundown Fish Oil 1000 MG
  12. Viga for Women tablets
  13. Viga Tablets (Naturalviagra) (2)
  14. VINAROL with VASX Tablets (2)

October 22, 2003

PRODUCT Mason Natural Chewable Calcium 600 with Vitamin D**Coffee Mocha Flavor tablet. A calcium/vitamin D supplement in a tablet dosage form, packed in plastic bottles with a white, blue, red, black and brown paper label. Recall # F-010-4.
CODE Lot 0656N Exp. 10/2005, Lot 0793N Exp. 12/2005.
RECALLING FIRM/MANUFACTURER Mason Distributors, Inc, Hialeah, FL, by letter on February 21, 2003. FDA initiated recall is complete.
REASON Dietary Supplement is misbranded in that it claims to be dairy free when it contains sodium caseinate, a milk-derived ingredient.
VOLUME OF PRODUCT IN COMMERCE 2,866-100 tablet bottles.
Distribution Nationwide.
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September 10, 2003
PRODUCT VINAROL with VASX Tablets, 500mg, blister packages of 2 or 7 tablets, Each tablet contains a proprietary blend of Cassia Tree, Dodder Seed, Epimedium, Wolfbery, Saling, Cistanche, Mangolia Vine Fruit, Red Raspberry, Narrow Leaved Polygala, Rehmannia Root, Eucommia Bark, Hindo Lotus Seed, Bidemate Bark, Milk Vetch Seed, Cherokee Rose, Arborviate Seed, American Ginseng, Ginkgo Biloba, Bionate International, Inc. Phoenix, AZ. Recall # D-326-3.
CODE Lot 030060 Exp 11/2006 thru 3/2007;
Lot 020245 Exp 11/2006 thru 3/2007.
RECALLING FIRM/MANUFACTURER Bionate International, Inc., Scottsdale, AZ, by press release on April 7, 2003, and by letters on May 27, 2003. Firm initiated recall is ongoing.
REASON Unapproved New Drug; product contains undeclared prescription drug sildenafil.
VOLUME OF PRODUCT IN COMMERCE 1-6 million tablets.
Distribution Nationwide.
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September 10, 2003
PRODUCT a) Viga Tablets (Naturalviagra), 200 mg, 20 and 30 count bottles and sample packets of 4 tablets, Ingredients:Ginseng, Oat straw, Melria puama, DHEA, Saw palmentto, Tribulus, Yohimbe, and Androstenedione, Inc. Recall # D-324-3;
b) Viga for Women tablets, 20 count bottles, (Natural Stimulant), Ingredients: Mauria Puama, Ginseng, Maca, Wild Yam, Damiana, L-Arginine, Dong Quai, Guarana, Horny Goat Weed, and Macuna Prurions Extract. Recall # D-325-3.
CODE Catalog numbers 10725 All Lots. b) Catalog numbers 10728 All Lots.
RECALLING FIRM/MANUFACTURER Best Life International Inc., Mayaguez, PR, by letter on May 23, 2003. Firm initiated recall is ongoing.
REASON Unapproved New Drug; product contains the undeclared prescription drug ingredient Sildenafil.
VOLUME OF PRODUCT IN COMMERCE 29,992 bottles.
Distribution Puerto Rico.
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September 10, 2003
PRODUCT

a) Viga Tablets (Naturalviagra), 200 mg, 20 and 30 count bottles and 4 tablet sample packets, Each tablet contains: Ginseng-40mg, Oat straw-10mg, Mauria puama-10mg, DHEA-10mg, Saw palmentto-40mg, Tribulus terrestris-40mg, Yohimbe extract-40mg, and Androstenedione-10mg. Recall # D-322-3;
b) Viga for Women tablets, BEST LIFE, 20 tablet bottles,Ingredients: Mauria Puama, Ginseng, Maca, Wild Yam, Damiana, L-Arginine, Dong Quai, Guarana, Horny Goat Weed, and Macuna Prurions Extract. Recall # D-323-3.
CODE All Codes.
RECALLING FIRM/MANUFACTURER Recalling Firm: RMA Laboratories, Inc., Paramount, CA, by press release on June 24, 2003, and by letters on May 12, 2003 through July 8, 2003. Manufacturing Firm: Health Nutrition Inc., Torrance, CA. and/or Best Life International, Inc. Firm initiated recall is ongoing.
REASON Unapproved New Drug; product contains undeclared prescription drug Sildenafil.
VOLUME OF PRODUCT IN COMMERCE Approx. 6 million tablets.
Distribution Nationwide.
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August 13, 2003
PRODUCT Sundown Fish Oil 1000 MG Dietary Supplement 120 Softgels Omega-3 Fatty Acids EPA/DHA Concentrate, packed in plastic bottles with screw on plastic caps. Recall # F-483-3.
CODE CODE Lot Number 357849.
RECALLING
FIRM/MANUFACTURER		 Rexall Sundown, Boca Raton, FL, by letter on April 8, 2002. Firm initiated recall is complete.
REASON Product labeled as Fish Oil Capsules consists in whole or in part of Vitamin E capsules.
VOLUME OF PRODUCT IN COMMERCE 35,000 120 capsule bottles.
Distribution Nationwide.
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May 14, 2003
PRODUCT Natural Treasures TMG Dietary Supplement, Trimethylglycine-Homocystine Manager, 60 capsules. Recall # F-367-3.
CODE Lot 001TMG9.
RECALLING
FIRM/MANUFACTURER		 American Supplement Technologies, Inc., Tempe, AZ, by letter on February 28, 2001. Firm initiated recall is complete.
REASON The dietary supplement contained smaller amount of Vitamin B12 than listed on the label.
VOLUME OF PRODUCT IN COMMERCE Undetermined.
Distribution Nationwide.
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March 26, 2003
PRODUCT a) Nature's Remedy Tablets, (Cascara sagrada 150mg and Aloe 100mg) Laxative, 15, 30 and 60 count foil-backed blistercard packages. Recall # D-174-3.
b) Nature's Remedy Tablets (Sennosides, USP 8.6mg) Stimulant Laxative, 15, 30, and 60 count foil-backed blistercard packages. Recall # D-175-3.
CODE a) Lot Number/Exp. Date: M0013 exp. 3/03; M0014 exp.3/03; M0015 exp. 4/03; M0016 exp. 4/03; M0017 exp. 4/03; M0018 exp. 4/03; M0019 exp. 4/03; M0020 exp. 4/03; M0021 exp. 4/03; M0023 exp. 4/03; M0024 exp. 4/03; M0025 exp. 4/03;M0026 exp. 4/03; M0028 exp. 4/03. 0022/TAX015 exp 4/03; 0029/TAZ016 exp. 4/03.
b) Lot No./Exp. Date: M 100133 1/03; M100133A 1/03; M103412 5/03; M103413 6/03; M103414 6/03; M106408 10/03; M106457 10/03; M106458 10/03; M106531 10/03; M106532 10/03; M200112 1/04; M200113 1/04; M200114 1/04; M201715 3/04; M201716 3/04; M201717 3/04; M202573 4/04; M202574 4/04; M202575 5/04; M202576 5/04; M202577 5/04; M202578 5/04; M202579 5/04; M202580 5/04; M202580A 5/04; M202581 6/04; M203643 6/04; M203757 6/04; M203758 6/04; M203759 6/04; M204427 7/04; M204427A 7/04; M204428 7/04; 140100637/LOT H MA/2003; 140103412/LOT I MA/2003; 140200097/LOT J and LOT M200097 JA/2004; 140202576/LOT K MA/2004.
RECALLING FIRM/MANUFACTURER Glaxo Smith Kline, Parsippany, NJ, by letters on January 23, 2003. Firm initiated recall is ongoing.
REASON a) Subpotent; active ingredient (Aloe) (stability 12 month timepoint).
b) Superpotent; active ingredient (stability 12 month timepoint)
VOLUME OF PRODUCT IN COMMERCE 1,289,220 units.
Distribution Nationwide and Canada.
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March 26, 2003
PRODUCT Labrada Nutrition brand Lean Body Hi Protein Meal Replacement Bar - Cookies & Cream flavor, Net. Wt. 78g, single serve nutritional bar wrapped in flexible film. Recall # F-283-2.
CODE Best by dates of 06/10/03 through 07/29/03.
RECALLING
FIRM/MANUFACTURER		 Elan Nutrition, L.L.C., Grand Rapids, MI, by letter on January 29, 2003. FDA initiated recall is ongoing.
REASON Product contains undeclared almond butter.
VOLUME OF PRODUCT IN COMMERCE 327,339 bars.
Distribution Nationwide.
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March 12, 2003
PRODUCT Biochem brand Ultimate Lo Carb Bar, Chocolate Brownie Nut, wrapped in flexible foil-like film, Net wt. 60 g (2.1 oz.).Recall # F-235-3.
CODE UPC #15794-18809 with the following lot numbers. APR1803S1, APR1803S6, APR1803W6, APR1803W1, APR1803H7, APR1803N6, APR1903S7, APR1903N7 and APR1903W7.
RECALLING
FIRM/MANUFACTURER		 Elan Nutrition, L.L.C., Grand Rapids, MI, by press release, telephone and letter on January 17, 2003. FDA initiated recall is ongoing.
REASON Product may contain undeclared peanut butter.
VOLUME OF PRODUCT IN COMMERCE 158,496 bars.
Distribution Nationwide.
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February 19, 2003
PRODUCT Re-Vita Liqua Health. Lemon-Lime Flavored Dietary Supplement labeled in part: 'Nutrients From Nature Liqua Health All in One Nutritional Assurance; The product is sold in 32 oz. plastic bottles, 16 oz. plastic bottles and 5 fl. oz. packets (packets further packaged in plastic bags with 10, 60, or 600 of these packets per bag). Each individual packet is labeled in part: 'Re-Vita Liqua Health (Lemon-Lime) Not For Individual Sale. See Master Packaging For Nutritional Information.' Recall # F-188-3.
CODE All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER Re-Vita Manufacturing Co., Inc., Orange Park, FL., by letter on December 13, 202. FDA initiated recall is ongoing.
REASON The product contained an undeclared color, FD&C Yellow No. 5.
VOLUME OF PRODUCT IN COMMERCE To be determined.
Distribution To be determined.
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February 19, 2003
PRODUCT Re-Vita Liqua Health. Lemon-Lime Flavored Dietary Supplement labeled in part: 'Nutrients From Nature Liqua Spirulina Energy Booster. The product is sold in 32 oz. plastic bottles, 16 oz. plastic bottles and 5 fl. oz. packets (packets further packaged in plastic bags with 10, 60, or 600 of these packets per bag). Each individual packet is labeled in part: 'Re-Vita Liqua spirulina (Lemon-Lime) Not For Individual Sale. See Master Packaging For Nutritional Information.' Recall # F-192-3.
CODE All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER Re-Vita Manufacturing Co., Inc., Orange Park, FL., by letter on December 13, 202. FDA initiated recall is ongoing.
REASON The product contained an undeclared color, FD&C Yellow No. 5.
VOLUME OF PRODUCT IN COMMERCE To be determined.
Distribution

To be determined.
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February 19, 2003
PRODUCT Re-Vita Liqua Health. Butternut flavor Dietary Supplement labeled in part: 'Nutrients From Nature Liqua Spirulina Energy Booster. The product is sold in 32 oz. plastic bottles, 16 oz. plastic bottles and 5 fl. oz. packets (packets further packaged in plastic bags with 10, 60, or 600 of these packets per bag). Each individual packet is labeled in part: 'Re-Vita Liqua Spirulina (Butternut) Not For Individual Sale. See Master Packaging For Nutritional Information.' Recall # F-190-3.
CODE All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER Re-Vita Manufacturing Co., Inc., Orange Park, FL., by letter on December 13, 202. FDA initiated recall is ongoing.
REASON The product contained an undeclared color, FD&C Yellow No. 5.
VOLUME OF PRODUCT IN COMMERCE To be determined.
Distribution To be determined.
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February 19, 2003
PRODUCT Re-Vita Liqua Health. Berry Flavored Dietary Supplement labeled in part: 'Nutrients From Nature Liqua Health All in One Nutritional Assurance; The product is sold in 32 oz. plastic bottles, 16 oz. plastic bottles and 5 fl. oz. packets (packets further packaged in plastic bags with 10, 60, or 600 of these packets per bag). Each individual packet is labeled in part: 'Re-Vita Liqua Health (Berry) Not For Individual Sale. Recall # F-186-3.
CODE All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER Re-Vita Manufacturing Co., Inc., Orange Park, FL, by letter on December 13,2002. FDA initiated recall ongoing.
REASON The product contained an undeclared color, FDC Red #40.
VOLUME OF PRODUCT IN COMMERCE To be determined.
Distribution To be determined.
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February 19, 2003
PRODUCT Re-Vita Liqua Health. Berry Flavored Dietary Supplement labeled in part: 'Nutrients From Nature LIQUA Spirulina Energy Booster. The product is sold in 32 oz. plastic bottles, 16 oz. plastic bottles and 5 fl. oz. packets (packets further packaged in plastic bags with 10, 60, or 600 of these packets per bag). Each individual packet is labeled in part: 'Re-Vita Liqua Spirulina (Berry) Not For Individual Sale. Recall # F-189-3.
CODE All codes are involved that do not list the referenced color.
RECALLING FIRM/MANUFACTURER Re-Vita Manufacturing Co., Inc., Orange Park, FL, by letter on December 13,2002. FDA initiated recall ongoing.
REASON Undeclared FDC Red #40.
VOLUME OF PRODUCT IN COMMERCE To be determined.
Distribution To be determined.
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February 19, 2003
PRODUCT Re-Vita Liqua Health. Grape Flavored Dietary Supplement labeled in part: 'Nutrients From Nature Liqua Health All in One Nutritional Assurance. The product is sold in 32 oz. plastic bottles, 16 oz. plastic bottles and 5 fl. oz. packets (packets further packaged in plastic bags with 10, 60, or 600 of these packets per bag). Each individual packet is labeled in part: 'Re-Vita Liqua Health (Grape) Not For Individual Sale. Recall # F-187-3.
CODE All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER Re-Vita Manufacturing Co., Inc., Orange Park, FL, by letter on December 13,2002. FDA initiated recall is ongoing.
REASON The product contained an undeclared color, FDC Red #40.
VOLUME OF PRODUCT IN COMMERCE To be determined.
Distribution To be determined.
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February 19, 2003
PRODUCT Re-Vita Liqua Health. Grape flavor Dietary Supplement labeled in part: 'Nutrients From Nature Liqua Spirulina Energy Booster. The product is sold in 32 oz. plastic bottles, 16 oz. plastic bottles and 5 fl. oz. packets (packets further packaged in plastic bags with 10, 60, or 600 of these packets per bag). Each individual packet is labeled in part: 'Re-Vita Liqua Spirulina (Grape) Not For Individual Sale. Recall # F-191-3.
CODE All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER Re-Vita Manufacturing Co., Inc., Orange Park, FL, by letter on December 13,2002. FDA initiated recall ongoing.
REASON The product contained an undeclared color, FDC Red #40.
VOLUME OF PRODUCT IN COMMERCE To be determined.
Distribution To be determined.
FDA Website: www.FDA.gov
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Last updated: 22 January 2009