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FDA Recalls (2004)

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U.S. Food & Drug Administration Actions: Recalls and Field Corrections Dietary Supplements -- 2004

  1. SportsOne Androstenedione
  2. Ultimate Nutrition Inc. ANDROSTENEDIONE
  3. Solutions IE Ageless Formula II, Ultra-Vitamins in Vegetable, Fruit and Herbal Base
  4. American Ginseng Capsules Manufactured by Now Foods
  5. Kick Start, High Energy Sparking Glucose Drink, 1 liter
  6. FLORIDA'S BEST NATURAL SINUS RELIEF
  7. Maxifed DM Tablets
  8. Bulk American Ginseng 648 mg Capsules containing 100% American Ginseng Powder (PANAX Ginseng Root)
  9. Disney Winnie the Pooh brand COMPLETE Multi Vitamin, Children's Multiple Vitamin and Mineral Supplement
  10. The Vitamin Shoppe brand American Ginseng
  11. American Ginseng, Jarrow Formulas
  12. Min-Tran Dietary Supplement Tablets
  13. Vitamin World American Ginseng; Puritan's Pride American Ginseng; Vitamin World Korean Ginseng; Puritan's Pride Korean Ginseng
  14. Boca Pharmacal, Inc. FE C Tab Plus, Rx only
  15. Stamina-Rx(tm) Tablets; Stamina-Rx(tm) for Women Tablets
  16. Vigor-Rx Capsules
December15, 2004
PRODUCT a) SportsOne Androstenedione 100 mg, 100 capsules Label
reads in part: *** SPORTS ONE * ANDROSTENEDIONE *
100 mg. DIETARY SUPPLEMENT * 100 capsules * Ingredients:
Each ... 100 mg. of Androstenedione. * Warning:
Androstenedione should not be used, Recall # F-090-5;
b) SportsOne ANDRO XS 600 mg, 60capsules Label reads
in part: SPORTS ONE * ANDRO * XS * Androstenedione
Tribulus Terrestris 600 mg. * 60 capsules *
Androstenedione 100 mg * Tribulus Terrestris 500 mg *
DIETARY SUPPLEMENT * Warning: This product should
not be used... * Recall # F-091-5.
CODE All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER Sports One Inc., New Haven, CT, by AP press release on March 11, 2004 and website on March 12, 2004. Firm initiated recall is complete.
REASON The product is adulterated since it contains the new dietary ingredient, androstenedione, for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
VOLUME OF PRODUCT IN COMMERCE Unknown.
Distribution Nationwide.
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December 8, 2004
PRODUCT ANDROSTENEDIONE, 100 mg, 100 capsule bottle UPC: 0 99907100034 7. Recall # F-082-5.
CODE Lot number: 111003 Exp. Date: 11/04.
RECALLING FIRM/MANUFACTURER Ultimate Nutrition Inc., Farmington, CT, by telecopy and letter on May 7, 2004. Firm initiated recall is complete.
REASON The product is adulterated since it contains the new dietary ingredient, androstenedione, for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
VOLUME OF PRODUCT IN COMMERCE 5,063 bottles.
Distribution CA, CT, FL, ID, MA, NJ, OH, PA, TX, WI, Curaco , UK , and Phillipines.
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November 24 2004
PRODUCT Solutions IE Ageless Formula II, Ultra-Vitamins in Vegetable, Fruit and Herbal Base, All 5 Network Anti-Oxidants, Folic Acid, Omega3 and 6, Noni Extract. Recall #F-076-5.
CODE All lots.
RECALLING FIRM/MANUFACTURER Aloe Commodities International, Inc., Carrolton, TX, by letter on March 19, 2004. Firm initiated recall is complete.
REASON The product contains excessive level of vitamin D. The product, labeled to contain 400 IU per the recommended dosage of 6 capsules daily, actually contains 188,640 IU per 6 capsules. The firm miscalculated the ingredient quantities during manufacture and reportedly added 8% Vitamin D3 instead of 0.08%.
VOLUME OF PRODUCT IN COMMERCE 1,600 bottles.
Distribution Nationwide.
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October 6 2004
PRODUCT American Ginseng Capsules, 5% Ginsenosides, 500 mg.; packaged in 50 capsule and 100 capsule bottles; Manufactured by Now Foods, marketed under the following labels:
a) Now American Ginseng, 50 capsule bottles, catalog 4002, UPC 33739-04002 and 100 capsule bottles, catalog 4004, UPC 33739- 04004 and catalog CN4004, UPC 33739-10411;
b) Nature’s Blessing Baar American Ginseng, 50 capsule bottles, catalog 4002 and 104002;
c) Take Your Vitamins American Ginseng, 50 capsule bottles, catalog 104002;
d) NaturaSalud Formulas Naturales Energy-2-Life, 50 capsule bottles, catalog 104002, UPC 33739-44002;
e) Oasis Vitamins American Ginseng, 50 capsule bottles, catalog104002, UPC 33739-44002;
f) Starfire International Panax qinquefolius American Ginseng, Sacramental-Healing, 50 capsule bottles, catalog 104002;
g) Dr. Lynne M.D. American Ginseng, 50 capsule bottles, catalog 104002, UPC 33739-44002;
h) Harvest Health Nutrition American Ginseng, 50 capsule bottles, catalog 104002, and 100 capsule bottles, catalog 4004 and 104004;
i) Pleasant Stone Farm American Ginseng, 100 capsule bottles, catalog 104004, UPC 33739-44004. Recall # F-547-4.
CODE 50 capsule bottles: catalog 4002, lots 355252, exp. 19-Jul-2004; 383363, exp. 09-Aug-2004; 397025, exp. 13-Oct-2004; 507305, exp. 13-Mar-2005; 517227, exp. 13-May-2005; 521807, exp. 08-Jun-2005; 527573, exp. 19-Jul-2005; 537291, exp. 18-Sep-2005; 541136, exp. 11-Oct-2005; 551235, exp. 04-Dec-2006; 566433, exp. 08-Feb-2007; catalog 104002, lots 378022, exp. 27-Jul-2004; 398432, exp. 19-Oct-2004; 494542, exp. 30-Dec-2004; 542303, exp. 16-Mar-2007; 596386, exp. 20-Jul-2007; 100 capsule bottles; catalog 4004, lot numbers 355113, exp. 18-Jul-2004; 377967, exp. 03-May-2007; 383998, exp. 12-Aug-2004; 399093, exp. 24-Oct-2004; 494381, exp. 23-Dec-2004; 506900, exp. 09-Mar-2005; 513904, exp. 25-Apr-2005; 519181, exp. 25-May-2005; 526333, exp. 14-Jul-2005; 533053, exp. 25-Aug-2005; 538044. exp. 22-Sep-2005; 542303, exp. 30-Apr-2007; 544053, exp. 07-Nov-2005; 556492, exp. 04-Jan-2007; 573579, exp. 05-Mar-2007; 596409, exp. 11-Jun-2007; 603862, exp. 06-Aug-2007; catalog CN4004, lot 555114, exp. 01-Jan-2007 catalog 104004, lots 355161, exp. 29-Jul-2005; 377967, exp. 06-Aug-2005; 560703, exp. 14-Jan-2007; 584802, exp. 20-Apr-2007; 585816, exp. 28-Apr-2007; 587227, exp. 05-May-2007; 604234, exp. 19-Jul-2007.
RECALLING FIRM/MANUFACTURER NOW Foods, division of The Fruitful Yield, Inc., Bloomingdale, IL, by letters dated August 30, 2004 and by telephone on September 3, 2004. Firm initiated recall is ongoing.
REASON The ginseng capsules contain quintozene, pentachloroaniline and oxadixyl, fungicides/pesticides that have no tolerances.
VOLUME OF PRODUCT IN COMMERCE 7,197 - 50 capsule bottles and 10,504 - 100 capsule bottles.
Distribution Nationwide and Internationally.
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Septemer 22 2004
PRODUCT Kick Start, High Energy Sparking Glucose Drink, 1 liter. The product is shipped in cartons of 12 units. The units are shrink wrapped in plastic. Recall # F-434-4.
CODE 3113 12:22 8/8 23 APR 04.
RECALLING FIRM/MANUFACTURER McElroy Imports, Glen Mills, PA, by telephone on June 17, 2004. Firm initiated recall is complete.
REASON The product contained the color sunset yellow FCF (certifiable as FD&C Yellow #6).
VOLUME OF PRODUCT IN COMMERCE 50 cases.
Distribution NY.
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July 28, 2004
PRODUCT FLORIDAíS BEST NATURAL SINUS RELIEF, (Purified Water, Saline, C-A-W Water, Eucalyptus Oil (0.7 Parts Per Mil), Peppermint), 1.5 OZ bottles. Recall # D-211-4.
CODE All products shipped prior to March 24, 2004. Product is uncoded.
RECALLING FIRM/MANUFACTURER JLT Industries, Longwood, FL, by letter on March 24, 2004. FDA initiated recall is complete.
REASON Microbial Contamination; product contains mold and yeast.
VOLUME OF PRODUCT IN COMMERCE Approximately 100 bottles.
Distribution Nationwide.
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July 14, 2004
PRODUCT Maxifed DM Tablets, Each sustained-release tablet contains: Guaifenesin 580mg, Pseudoephedrine HCl 60mg, Dextromethorphan HBr 30mg, 100 count bottles, Rx Only,
NDC 58605-626-01. Recall # D-179-4.
CODE 3M05.
RECALLING FIRM/MANUFACTURER Pharmakon Laboratory, Inc, Tampa, FL, by letter dated June 17, 2004. Firm initiated recall is ongoing.
REASON The caplets are embossed as ìMAXIPHEN DMî rather than ìMAXIFED DMî.
VOLUME OF PRODUCT IN COMMERCE 2,010.
Distribution Nationwide.


PRODUCT Bulk American Ginseng 648 mg Capsules containing 100% American Ginseng Powder (PANAX Ginseng Root). Product: American Ginseng Caps, Lot #: 034632, Quantity: 13m, Product #: VS-2064. IMPORTANT: This container is intended for BULK SHIPPING ONLY. The contents should be repacked WITHIN 90 DAYS into tightly closed containers. The manufacturer does not assume responsibility for any changes in physical appearance or potencies when these instructions are disregarded. -- Labeling for repacked product: The Vitamin Shoppe brand American Ginseng 648 mg, 100 CAPSULES, Herbal Supplement, Lot 169-1006-1021 EXP 10-2006. Recall # F-276-4.
CODE Bulk Product No. VS-2064, Bulk Lot No. 034632.
RECALLING FIRM/MANUFACTURER Nature's Value, Inc., Bay Shore, NY, by letter on May 7, 2004. FDA initiated recall is ongoing.
REASON American Ginseng 648 mg capsules Bulk Lot No. 034632 were analyzed by SRL and found to be contaminated with pesticides.
VOLUME OF PRODUCT IN COMMERCE 95,000 capsules.
Distribution NJ.
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June 30, 2004
PRODUCT Disney Winnie the Pooh brand COMPLETE Multi Vitamin, Childrenís Multiple Vitamin and Mineral Supplement, 60 chewable tablets. Prod. No. 13551. Recall # F-261-4.
CODE All lots on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER NBTY, Inc., Bohemia, NY, by telephone on May 24-25, 2004, and by letters dated May 25, 2004. Firm initiated recall is ongoing.
REASON Labeling of this dietary supplement containing iron lacked the required "WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately" .
VOLUME OF PRODUCT IN COMMERCE 1,336 cases (12 units per case).
Distribution Nationwide.
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June 23, 2004
PRODUCT a) The Vitamin Shoppe brand;American Ginseng 648mg;
capsules, 100 hard gelatin capsule bottle.
Recall # F-252-4;
b) The Vitamin Shoppe brand;Ginseng Complex; capsules, 100
and 300 hard gelatin capsule bottles, American Ginseng
200mg; Korean Ginseng 200mg; Red Chinese Ginseng 200mg;
Eleuthero 200mg; Royal Jelly Extract 57mg/capsule.
Recall # F-253-4.
CODE a) Product code: VS-2064, 1071847;
b) Product codes: VS-2076, 1072392 -- 100 capsule bottles;
VS-2077, 1072392 -- 300 capsule bottles; VSU-6066,
1132710 -- Kosher, Vegicaps, 100 capsule bottles.
RECALLING FIRM/MANUFACTURER Vitamin Shoppe Industries, Inc., North Bergen, NJ, by e-mails on February 6, 2004. FDA initiated recall is complete.
REASON Capsules contain pesticide contaminants.
VOLUME OF PRODUCT IN COMMERCE 21.084 bottles.
Distribution Nationwide.


PRODUCT American Ginseng, Jarrow Formulas, 7% Ginsenosides, 50 and 100 capsules, 500 mg, 12 bottles per case. Recall # F-259-4.
CODE a) For the 50 capsules per bottle - When customers are ordering this product, the name code is AMG and the number code is 14017. Two bottling productions resulting in codes that are either Lot # Best Used Before: 16994L2 12/2004 or Lot # Best Used Before: 12113C3 03/2005;
b) For the 100 capsules per bottle ‚ When customers are ordering his product, the name code is AMGS and the number code is 14018. Two productions resulting in codes that are either Lot # Best Used Before: 1972B3 07/2005 or Lot # Best Used Before: 1324H2 08/2004.
RECALLING FIRM/MANUFACTURER Jarrow Formulas, Inc., Los Angeles, CA, by telephone on November 21, 2003. FDA initiated recall is complete.
REASON Ginseng capsules contain pesticide contaminants.
VOLUME OF PRODUCT IN COMMERCE 1.730 bottles.
Distribution Nationwide.
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May 12, 2004
PRODUCT Min-Tran Dietary Supplement Tablets in bottles of 330 and
800 tablets per bottle. Recall # F-188-4.
REAN GINSENG, Panax ginseng, NATURAL WHOLE HERB, 500 mg, 100 CAPSULES. Recall # F-154-4.
CODE Code L318, Best Used By 09-05.
RECALLING FIRM/MANUFACTURER Standard Process, Inc., Palmyra, WI, by telephone on December 15, 2003, and by letter on December 16, 2003. Firm initiated recall is complete.
REASON Min Train Tablets are contaminated with mold.
VOLUME OF PRODUCT IN COMMERCE 1024 bottles of 800 count bottles; 4974 bottles of 330 count bottles.
Distribution Nationwide.
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April 7, 2004
PRODUCT a) American Ginseng, 500 mg, 30 capsules. Product No.
5595. Distributed in plastic bottles under the following labels & labeling:
(1) VITAMIN WORLD AMERICAN GINSENG, Panax quinquefolium, 100% Pure Grown in America, Minimum 4% Ginsenosides (or Minimum 8% Ginsenosides depending on label) 500 mg, 30 CAPSULES. (2) Puritan's Pride AMERICAN GINSENG, Panax quinquefolium, 100% Pure grown in America, 500 mg, 30 CAPSULES. Recall # F-153-4;
b) KOREAN GINSENG, 500 mg, 100 CAPSULES, PROD. NO. 5021. Distributed in plastic bottles under the following labels & labeling: (1) VITAMIN WORLD KOREAN GINSENG, Panax ginseng, 500 mg, 100 CAPSULES. (2) Puritan's Pride KOREAN GINSENG, Panax ginseng, NATURAL WHOLE HERB, 500 mg, 100 CAPSULES. Recall # F-154-4.
CODE All lots.
RECALLING FIRM/MANUFACTURER NBTY, Inc., Bohemia, NY, by memorandums dated October 31, 2003 and November 14, 2003. FDA initiated recall is ongoing.
REASON Certain lots of Ginseng were found to be contaminated with pesticides based on FDA's analyses.
VOLUME OF PRODUCT IN COMMERCE Unknown.
Distribution Nationwide, HA, PR, Guam and St. Thomas, VI.
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February 18, 2004
PRODUCT BOCA PHARMACAL, INC FE C Tab Plus, (Carbonyl Iron 100 mg, Vitamin C (Ascorbic Acid) 250 mg, Vitamin B-12 (Cyanocobalamin) 25 mcg, Folic Acid 1 mg), Rx only. Recall # D-109-4.
CODE Lot Number: 18317, Expiration Date: (10/2005).
RECALLING FIRM/MANUFACTURER Gemini Pharmaceuticals, Inc., Commack, NY, by telephone on January 22, 2004 and letter on January 27, 2004. Firm initiated recall is ongoing.
REASON Mislabeling: Tablets lack the identifying debossment (ID# "G-3") on one side.
VOLUME OF PRODUCT IN COMMERCE 5,000 bottles.
Distribution Nationwide.
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January 21, 2004
PRODUCT a) Stamina-Rx(tm) Tablets, Maximum Sexual Stimulant, a dietary supplement, sold over-the-counter, in bottles of thirty tablets (30) and individual sample packets of two (2) 550 mg tablets labeled to contain a combination of herbal ingredients for use as a sexual stimulant. The primary ingredients (per tablet) listed on the product's labeling include the following: Epimedium Extract (leaves) Yohimbe Extract (bark), (8mg Yohimbine alkaloids), Cnidium Extract (fruit), Xanthoparmelia Scabrosa Extract (lichen), Gamma Amino Butyric Acid, and L-Arginine. The product's labeling recommends a dosage of 1 to 2 tablets prior to sexual activity. Recall # D-094-4.
b) Stamina-Rx(tm) for Women Tablets, MAXIMUM SEXUAL ENHANCER, Adult Dietary Supplement, sold over-the-counter, in bottles of twelve (12) and thirty (30), as well as, sample packets of two (2) 350 mg tablets labeled to contain a combination of herbal ingredients to increase sexual desire, stamina, and arousal. The primary ingredients (per tablet) listed on the product's labeling include the following: Mauria Puama, Epimedum (leaves/stems) 50% Extract, Mucuna Pruriens (seed), Herba Cistanches (root), Xanthoparmelia Scabrosa (lichen), Cnidu Monnier (fruit), Yohimbe 8% (bark), yields 2 mg Yohimbine Alkaloids, Ageratum (root), Gingko Biloba (leaves), and L-Arginine HCL. The product's labeling recommends a dosage of 1 to 2 tablets an hour prior to sexual activity. Recall # D-095-4.
CODE a) Lot #03141220, Expiration May 2005; Manufactured May
2003: Lot #02141484, Expiration August 2005,
Manufactured August 2002 and Lot #03141163, Expiration
April 2005, Manufactured April 2003. Lot Nos. 141-363,
141-364, 141-365, 141-366, 141-367, 141-368, 141-369,
141-370, 141-444, 141-445, 141-446,141-447 and 141-448.
b) Lot #02143579, Expiration September 2005, Manufactured
September 2002.
RECALLING FIRM/MANUFACTURER Hi-Tech Pharmaceuticals, Inc., Norcross, GA, by letters dated August 18 and 19, 2003 and December 8, 2003. Firm initiated recall is ongoing.
REASON Unapproved New Drug; product contains undeclared prescription ingredient Tadalafil.
VOLUME OF PRODUCT IN COMMERCE 1 million tablets per lot (4882 Cases (Blister packs)).
Distribution Nationwide.
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January 21, 2004
PRODUCT

Vigor-Rx Capsules, Pharmaceutical Grade Dietary Supplement, sold over-the-counter, in bottles of sixty (60), 545 and 1002 mg capsules, labeled to contain a combination of herbal ingredients for advanced support of healthy erectile function. The primary ingredients (per capsules) listed on the product's labeling include the following: Maca Extract (root), Muira Puama Extract (root), Epimedium Extract (leaves/stems), Cnidium Extract (fruit), Xanthoparmelia Scabrosa Extract (lichen), L-Arginine, Erin Tree Extract (bark), Tribulus Extract (fruit), and Forskohlii Extract (root). Packed in clear plastic bottles, containing blue, hard gelatin capsules, marked with three white bands and VIGOR-Rx. The product's labeling recommends a dosage of 1 to 2 capsules 30 to 45 minutes prior to sexual activity. Recall # D-100-4.

CODE Lot #0310484, Expiration March 2005, Manufactured March 2003.
RECALLING FIRM/MANUFACTURER National Urological Group, Inc., Norcross, GA, by letter on September 8, 2003. Firm initiated recall is ongoing.
REASON Unapproved New Drug: tablets contain the undeclared prescription ingredient tadalafil.
VOLUME OF PRODUCT IN COMMERCE One million capsules (16,666 bottles).
Distribution Nationwide.
FDA Website: www.FDA.gov
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Last updated: 24 October 2007