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FDA Recalls (2005)

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U.S. Food & Drug Administration Actions: Recalls and Field Corrections Dietary Supplements -- 2005

  1. Liqiang 1 Herbal Supplement Capsules
  2. CVS brand Multi-vitamin & Multi-mineral Dietary Supplements
  3. Brooks brand Dairy Digestive Supplement, Lactase Enzyme
  4. Assi Brand Dried Bellflower Root
  5. Nature's Plus brand Animal Parade Children's Chewable Calcium Tablets, Natural Vanilla Sundae Flavor
  6. DOUBLE DEERS FORMULA brand EXPELLIN EXTRACT (CONCENTRATED), DIETARY HERBAL SUPPLEMENT, CHUAN XIONG
    CHA TIAO WAN
  7. Enzyte tablets
  8. Assi Brand Dried Bellflower Root
  9. Actra-Rx Gentlemen Nutritional Supplement Capsules
  10. Nature's Plus The Energy Supplements
  11. Ferrous Sulfate (iron) 27 mg tablets in plastic bottles packed under 5 different labels
  12. Male Power Plus, maximum strength male sexual stimulant oral tablets
  13. Alternative Health & Herbs Remedies-various products
  14. Up Your Gas Energy Booster, Dietary Supplement Caplets
  15. Majestic Royal Jelly 1000 mg. Plus Ginseng
  16. Icar Pediatric Suspension, Iron supplement
  17. Starwest brand Fenugreek Seeds in 100 capsule bottles
  18. Sanapac's Vee 200 for Men
  19. E'OLA Ultra-S, Super Strength and E'OLA Ultra-S
  20. Bulk American Ginseng 550 mg Capsules containing 100% American Ginseng Powder (Panax quinquefolius)
  21. NATURE**Sex. Plex for Him, Nature**Sex.Plex for Her, and Viga


December28, 2005
PRODUCT a) Liqiang 1 Herbal Supplement Capsules, (Codonopsis
67.5mg, Astragalus Root 67.5mg, Figwort Root
67.5mg, Mai Dong 45.00mg, Sciomon’s Root
67.5mg, Anemarrena 37.35mg, Polygonatum
37.35mg and Tian Hua Fen 60.30mg)90 Caps
x 450 mg bottles, Recall # D-072-6;
b) Liqiang 4 Herbal Supplement Capsules, (Codonopsis
67.5mg, Astragalus Root 67.5mg, Red Sage Root
13.5mg, Poria Rubra 38.25mg, White Atractylodes
67.5mg, Rehmannia 67.5mg, Chinese Wolberry Root
Bark 90mg, and Wild Yam 38.25mg)90 Caps x 450 mg
bottles, Recall # D-073-6;
c) Liqiang 5 Capsules, (Trichosanthes Root,
Dried Rehmannia Root, Figwort Root, and Chinese
Magnoliavine), 90 Caps bottles, Recall # D-074-6
CODE All lots and codes
RECALLING FIRM/MANUFACTURER Recalling Firm: Bugle International, Inc., Northridge, CA, by telephone and fax beginning on June 17, 2005.
Manufacturer: Henan Yilong Import & Export Co. Limited, Zhengzhou, China. Firm initiated recall is ongoing.
REASON Unapproved New Drug found to contain undeclared prescription drug Glyburide.
VOLUME OF PRODUCT IN COMMERCE 128,000
Distribution Nationwide and Canada.
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September 14, 2005
PRODUCT Multi-vitamin & multi-mineral dietary supplement. Distributed under the following labels & labeled in part: 1) CVSÆ pharmacy xxx SPECTRAVITE USP xxx MULTIVITAMIN/MULTIMINERAL xxx with antioxidant vitamins C, E & beta carotene ** xxx NOW WITH HEART HEALTHY LYCOPENE** xxx 60 TABLETS xxx DIETARY SUPPLEMENT xxx Prod. No. 41771 xxx Product No. 41771, UPC bar code # 0 50428 61854 7, (2) SundownÆ xxx ADVANCED SunViteÆ xxx High in Antioxidants xxx Multi-Vitamin and Multi-Mineral Formula xxx 130 Tablets xxx MULTI SUPPLEMENT xxx, Product No. 44811, UPC bar code # 0 30768 13798 4, Recall # F-626-5
CODE CVS brand: all lots; Sundown brand: lot numbers 67076-01, 66115-04, 66114-05, 66114-04, 66114-03, 66114-01
RECALLING FIRM/MANUFACTURER NBTY Inc, Bohemia, NY, by telephone on August 17, 2005 and by letters dated August 22, 2005 and August 23, 2005. Firm initiated recall is ongoing.
REASON The labeling of the dietary supplements failed to include the required accidental overdose warning statement for iron-containing products.
VOLUME OF PRODUCT IN COMMERCE CVS SpectraVite: approx. 175,254 - 60 tablet bottles; Sundown SunVite: approx. 19,515 - 130 tablet bottles.
Distribution Nationwide.

PRODUCT Brooks brand Dairy Digestive Supplement, Lactase Enzyme, chew or swallow; 3,000 FCC units per caplet in a bottle of 60 caplets; UPC # 8459700255, Recall # F-632-5.
CODE Lot 5EV0221; exp. 05/07
RECALLING FIRM/MANUFACTURER Recalling Firm: Perrigo Company, Allegan, MI, by letter on July 18, 2005.
Manufacturer: JB Laboratories, Inc, Holland, MI. Firm initiated recall is ongoing.
REASON The bottle label is mislabeled as extra strength, when the product is actually regular strength. The carton is labeled correctly.
VOLUME OF PRODUCT IN COMMERCE 2,160 bottles
Distribution Nationwide.
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September 7, 2005
PRODUCT Assi Brand Dried Bellflower Root, net wt. 16 oz, packaged in plastic bags***Product of China, Recall # F-419-5.
CODE Item code "06034K" printed on the package. The product is not coded by lot number.
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.

PRODUCT Nature's Plus brand Animal Parade Children's Chewable Calcium Tablets, Natural Vanilla Sundae Flavor, Recall # F-621-5.
CODE 90-count bottles: Product #s 29996, E2999601, E2999602; Lot numbers 1021176, 1026101, 1027564, 1031816, 1034956, 1036178, 1037365, 1040904, 1042758, 1044825, 1047386, 1047393, 1047525, 1048517,1050151, 1050154, 1051997, 1053348, 1053973, 1054445, 1057193, 1057397, 1057707, 1060047, 1060499, 1060500,1060806, 1061489, 1061901, 1061981, 1063812, 1064562, 1064940, 1065113, 1066328, 1066447, 1069110, 1070316, 1073315, 1074734, 1075490, 1076653, 1070724, 1077869, 1079306, 1081876, 1082099. Sample packets: Product # 79996, Lot numbers 03703A, 1037089, 14204A, 19703C, 27203A, 32103A, A31902.
RECALLING FIRM/MANUFACTURER Recalling Firm: Natural Organics, Melville, NY, by press release on December 2, 2004, and by letters dated December 3, 2004.
Manufacturer: Organics Laboratories, Inc., Amityville, NY. Firm initiated recall is ongoing.
REASON Product contains undeclared sodium caseinate, a milk derivative which poses a health risk to individuals that are allergic to milk.
VOLUME OF PRODUCT IN COMMERCE 128,915 bottles and 73,134 sample packets
Distribution Nationwide and Internationally
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August 31, 2005
PRODUCT a) DOUBLE DEERS FORMULA brand EXPELLIN EXTRACT
(CONCENTRATED), DIETARY HERBAL SUPPLEMENT, CHUAN XIONG
CHA TIAO WAN --- CONTENTS 200 PILLS (160 mg each) ---
Net Wt. 1.13 OZ (32g), PRODUCT OF CHINA ---Supplement
Facts --- Serving size 8 pills (1280 mg) --- Servings
per container 25 --- Proprietary blend 1280 mg ---
Chinese mint (above ground parts) --- Fragrant angelica
(root) ---Notopterygium (root & rhizome) --- Ligusticum
wallichii (rhizome) --- Siler (root) --- The pills are
packed in amber plastic bottles with safety caps and
packaged into green cardboard boxes with black lettering
on the white panel & red line. Recall # F-599-5;
b) CARDIOFLEX (GUAN XIN SU HE WAN) DIETARY SUPPLEMENT ---
CONTENTS: 30 PILLS (500mg Each) NET WT. 0.53 OZ. (20g),
PRODUCT OF CHINA --- Supplement Facts --- Serving Size
1 PILL --- Servings per container 30 --- Proprietary
blend 500 mg+ --- Santalum wood (Santali lignum)(root)
--- Aristochia root (Radix aristolochiae )(root) ---
Myrrh resin (Myrrha) (root) --- Scarlet root (Salvia
militorrhiza)(root) --- Styrax resin (Styrax
obassia)(root) --- The pills are packed in white plastic
bottles with safety caps and packaged into white
cardboard boxes with black lettering and pink & blue
colored stripes. Recall # F-600-5
CODE All lots.
RECALLING FIRM/MANUFACTURER Recalling Firm: Kingsway Trading Inc., Brooklyn, NY, by Press Release on November 10, 2004, and letters dated November 16, 2004.
Manufacturer: Shanghai Chinese Herbal CO., LTD. Shanghai People's Republic of China. Firm initiated recall is complete.
REASON FDA's analysis revealed that the products contain Aristolochic Acid, a potent carcinogen and nephrotoxin found in certain plants and botanicals.
VOLUME OF PRODUCT IN COMMERCE a) 80 cartons x 120 bottles (9,600 bottles);
b) 4,562 bottles
Distribution Nationwide.



PRODUCT Enzyte tablets, packaged in 30 count tablet packages. Recall # F-583-5.
CODE Lot 0447K4
RECALLING FIRM/MANUFACTURER Recalling Firm: Berkeley Premium Nutraceuticals, Inc., Cincinnati, OH, by letter on or about January 25, 2005.
Manufacturer: Garden State Nutritionals, West Caldwell, NJ. Firm initiated recall is ongoing.
REASON The product label incorrectly identifies the total quantity of Enzyte Premium Blend as 2000 mg. The correct total quantity of the Enzyte Premium Blend is 640 mg.
VOLUME OF PRODUCT IN COMMERCE 200/30 count tablet packages.
Distribution Nationwide
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June 8, 2005
PRODUCT Assi Brand Dried Bellflower Root, net wt. 15 oz, packaged in plastic bags labeled in part***06034K***Product of China***. Recall # F-419-5.
CODE Dried Bellflower Root product is identified by item code "06034K" printed on the package. The product is not coded by lot number.
RECALLING FIRM/MANUFACTURER Recalling Firm: Rhee Brothers Incorporated, Columbia, MD, by Press Release on April 28, 2005 and letters on April 30, 2005.
Manufacturer: Zibo Juyuan Food Co., Ltd., Shandong, China. Firm initiated recall is ongoing.
REASON Imported food product contains undeclared sulfites. Sensitized individuals may run risk of serious life-threatening allergic reactions if they consume product.
VOLUME OF PRODUCT IN COMMERCE 4,640 packages
Distribution Eastern US and Canada.
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May 25, 2005
PRODUCT Actra-Rx Gentlemen Nutritional Supplement Capsules, Proprietary Blend: Amino acid blend (Proline, Histidine, Glutamic Acid, Argenine, Aspartic Acid, Tyrosine, Phenylalanine, Lysine, Leucine, Glycosine, Threonine, iso-Leucine, Alanine, Senine, Methionine, Trytophane and Cystis Acid) Lycium (Fruit), Epimedium (Herb) Cistanche (Root) Vitamins B1, B2 and Minerals, 450mg, 5 count bottles, No Preservatives Added. Recall # D-234-5.
CODE Lot 001-3, Exp date December 2005.
RECALLING FIRM/MANUFACTURER Recalling Firm: Body Basics Inc,. Canoga Park, CA, by FDA issued press release on Nov. 2, 2004. Manufacturer: Shenyang Chang Gang Yibao Alcohol Co., Ltd, Shenyang, Liaoning, Mainland China. Firm initiated recall is complete.
REASON Unapproved New Drug; contains undeclared sildenafil citrate.
VOLUME OF PRODUCT IN COMMERCE 15,000 tablets.
Distribution Nationwide.
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May 18, 2005
PRODUCT Nature's Plus The Energy Supplements --- HERBAL ACTIVES --- KOREAN GINSENG --- 250 MG/15% GINSENOSIDES --- STANDARDIZED BOTANICAL SUPPLEMENT --- MAXIMUM GUARANTEED POTENCY --- PRESCRIPTION QUALITY --- 60 CAPSULES --- PRODUCT NO. 7216. The product is a clear gelatin oval capsule contained in a 60 count white plastic bottle with an inner seal; Bottle contains an insert. Bar code # 0 97467 07216 9. Recall # F-344-5.
CODE Lots: 1047806, 1052379, 1056527, 1067219, 1076347.
RECALLING FIRM/MANUFACTURER Recalling Firm: Natural Organics, Melville, NY, by letters dated March 24, 2005.
Manufacturer: Natural Organics Laboratories, Inc., Amityville, NY. Firm initiated recall is ongoing.
REASON Raw material ginseng extract and bulk ginseng capsules were found to be contaminated with pesticides based on FDA's analysis.
VOLUME OF PRODUCT IN COMMERCE 2,397 bottles.
Distribution Nationwide and Internationally.
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April 13, 2005
PRODUCT a) Ferrous Sulfate (iron) 27 mg tablets in plastic bottles packed under 5 different labels:
Pharmacist’s Choice brand IRON 96 TABLETS; select brand FERROUS SULFATE 100 TABLETS; FERROUS SULFATE 100 TABLETS Superior brand; OPTIMUM brand FERROUS SULFATE 100 TABLETS; OPTIMUM brand FERROUS SULFATE 250 TABLETS. Recall # F-244-5;
b) Prenatal vitamins, 100 tablets in plastic bottles packed under 3 different labels:
BARTELL DRUGS brand Prenatal Formula Multivitamin and Mineral; select brand PRENATAL TABLETS Multiple Vitamins & Minerals Supplement for Pregnant or Lactating Women; OPTIMUM brand PRENATAL FORMULA Multivitamin & Mineral Dietary Supplement. Recall # F-245-5;
c) Vitamin B-6 100 mg, 100 tablets in plastic bottles packed under 3 different labels: OPTIMUM brand; SELECT brand; BARTELL DRUGS brand. Recall # F-246-5;
d) Vitamin B-12 Sublingual 500 mcg, 100 tablets in plastic bottles labeled under 3 brands: SELECT brand; OPTIMUM brand; BARTELL DRUGS brand. Recall # F-247-5;
e) Vitamin B-12 100 mcg in 100 tablet plastic bottle under select brand label. Recall # F-248-5;
f) Niacin 100 mg 100 tablets in plastic bottle, select brand. Recall # F-249-5;
g) Vitamin C-500 mg USP in plastic bottles packed under 3 brands: Superior brand 100 tablet & 500 tablet bottles; BARTELL DRUGS brand in 100 tablet and 500 tablet bottles; OPTIMUM brand 100 tablets. Recall # F-250-5;
h) Selenium 200 mcg 60 tablet plastic bottles packed under two brands: OPTIMUM brand; SELECT brand. Recall # F-251-5;
i) Folic Acid 800 mcg USP, 250 tablet plastic bottle, OPTIMUM brand. Recall # F-252-5.
CODE a) Lot #s 329539, 329540, 330166, 330165, 330909; all with expiration 11/07;
b) Lot #s 329796, 330168, 330169, 330683, 330883; all with expiration 10/07;
c) Lot #s 329714, 329578, 329164, 330487, 330684; all with expiration 11/07;
d) Lot #s 329640, 329904, 329992, 330046; all with expiration 11/07;
e) Lot #s 329641, 330393; expiration 11/07. Lot #s 327920, 328935, 329508; expiration 9/07;
f) Lot #s 329541, 329826, 330687; all with expiration date 11/08;
g) Lot #s 329109, 329355, 329490, 329430, 330183; all with expiration 10/08;
h) Lot #s 329926, 330053, 330194, 331116; all with expiration date 11/07;
i) Lot # 330375, expiration date 11/07.
RECALLING FIRM/MANUFACTURER Magno Humphries, Inc., Tigard, OR, by telephone beginning on March 8, 2005 and by letter on March 9, 2005. Firm initiated recall is ongoing.
REASON Products may contain metal fragments.
VOLUME OF PRODUCT IN COMMERCE 26,110 bottles.
Distribution Nationwide.



PRODUCT Male Power Plus, maximum strength male sexual stimulant oral tablets, OTC, sold as a Dietary Supplement. Recall # D-181-5.
CODE All codes.
RECALLING FIRM/MANUFACTURER Spectrum Distribution & Marketing, Inc., Beverly Hills, CA, by letters on November 29, 2004, and press release on December 1, 2004. Firm initiated recall is ongoing.
REASON Product contains undeclared Taladafil.
VOLUME OF PRODUCT IN COMMERCE 105,000 tablets.
Distribution Nationwide.

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March 23 , 2005
PRODUCT a) Health & Herbs Eye Rinse Concentrate Formula
1036 Herbal Tincture in 2 fl. oz. amber bottles
with black glass dropper. Recall # D-143-5;
b) White Willow Bark (3193) Herbal Tincture in 2 fl.
oz. amber bottles with black glass dropper.
Recall # D-144-5;
c) Fennel Seed 3126 Herbal Tincture in 2 fl.
oz. amber bottles with black glass dropper
and 8 oz. bottles. Recall # D-145-5;
d) Elderberry Flower 3247 Herbal Tincture in 2 fl.
oz. amber bottles with black glass dropper and
32 oz glass bottle. Recall # D-146-5.
CODE Not all bottles are coded. Some of the bottles have fill dates on them, however the dating system used by each employee was not systematic.
RECALLING FIRM/MANUFACTURER Alternative Health & Herbs Remedies, Albany, OR, by press releaseon December 2, 2004, by telephone on December 3, 2004, and by letter beginning on December 6, 2004. Firm initiated recall is ongoing.
REASON Non-Sterility.
VOLUME OF PRODUCT IN COMMERCE a) 87/2 oz. bottles;
b) 41/2 oz. bottles;
c) 35/2 oz. bottles and 1/8 oz bottle;
d) 8/2 oz. and 1/32 oz. bottles.
Distribution Nationwide.

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March 16, 2005
PRODUCT

Up Your Gas Energy Booster, Dietary Supplement Caplets. 60 tablets per bottle. Ingredients include extracts of ginseng, guarana seed, kola nut, yerba mate leaf and niacin. Recall # F-206-5.
CODE Lot # 109810804, EXP Date 08/07.
RECALLING FIRM/MANUFACTURER Nutrition Formulators, Inc., Miami Lakes, FL, by letter on December 1, 2004. Firm initiated recall is ongoing.
REASON The product contains pesticide contaminants.
VOLUME OF PRODUCT IN COMMERCE 3,480 bottles of 60 each tablets.
Distribution FL.

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March 9, 2005
PRODUCT

Majestic Royal Jelly 1000 mg. Plus Ginseng, Made in the U.S.A., in bottles of 10 capsules and 30 capsules per bottle. Recall # F-194-5.
CODE Lot # 1005004, NFS Code #1516-C, Exp 10/2007.
RECALLING FIRM/MANUFACTURER Nutritional Food Supplements, Copiague, NY, by telephone, fax and mail on or about December 20, 2004. Firm initiated recall is complete.
REASON The ginseng powder raw material supplied to the firm was found to be contaminated with pesticides.
VOLUME OF PRODUCT IN COMMERCE 1,400 bottles (30 capsules per bottle) and 700 bottles (10 capsules per bottle).
Distribution Jordan.


PRODUCT

Icar Pediatric Suspension, Iron supplement, 4 fl ounces, NDC 63717-102-04. Recall # F-197-5.
CODE Lot numbers: 2J03 exp 09/04, 2L09 exp 11/04, 3C02 exp 02/05, 3C03 exp 02/05, 3D02 exp 03/05, 3H04 exp 07/05, 3H05 exp 07/05, 3I02 exp 08/05, 3I03 exp 08/05, 3K05 10/05, 3K07 exp 10/05, L402002 exp 01/06, L403001 exp 02/06, L404001 exp 03/06.
RECALLING FIRM/MANUFACTURER Cypress Pharmaceutical, Inc., Madison, MS, by letters on May 26, 2004 and June 4,2004. Firm initiated recall is complete.
REASON Potential problems with dosage due to the precipitation of suspending agent.
VOLUME OF PRODUCT IN COMMERCE 46,846.
Distribution Nationwide.
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February 23, 2005
PRODUCT

Starwest brand Fenugreek Seeds in 100 capsule bottles, item #: 498400-06. The product is in 440 mg capsules. This is a dried herb that has been milled to a powder form. Recall # F-176-5.
CODE C3816, Exp. 11/06.
RECALLING FIRM/MANUFACTURER Starwest Botanicals Inc., Rancho Cordova, CA, by telephone and letter on beginning on December 15, 2004. Firm initiated recall is complete.
REASON Product labeled as "Fenugreek Seeds" actually contains Scullcap.
VOLUME OF PRODUCT IN COMMERCE 47/100-capsule bottles.
Distribution CA, WA, IN, CT, and NY.
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February 16, 2005
PRODUCT

Sanapac's Vee 200 for Men. The product is sold in 90 cc and 120 cc bottles of 30 and 50 tablets and shipped in cases containing 12 bottles. Recall # F-185-5.

CODE Lot numbers 1099, 7021, 0281, 0254, 0303, and 0491.
RECALLING FIRM/MANUFACTURER Sanapac Co., Dallas, PA, by letter dated January 12, 2005. Firm initiated recall is ongoing.
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 288 bottles.
Distribution NC.
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February 2, 2005
PRODUCT

a) E'OLA Ultra-S, Super Strength, 8 oz liquid.
Product labeling reads in part: "Ultra S SUPER
STRENGTH *** DIETARY SUPPLEMENT NET WEIGHT 8
FLUID OZ (24O ml)". Recall # F-160-5;
b) E'OLA Ultra-S, 8oz liquid. Product label reads
in part: "E'OLA ULTRA-S *** Purified Silver in
Solution Dietary Supplement NET WEIGHT 8 FLUID Oz.
(240 ml.)". Recall # F-161-5.
CODE a) Item code 11365;
b) Item code 11363.
RECALLING FIRM/MANUFACTURER Biogenics, Inc., Saint George, UT, by letter on August 28, 2003. Firm initiated recall is complete.
REASON Product makes drug claims.
VOLUME OF PRODUCT IN COMMERCE 6,397 units.
Distribution Nationwide.
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January 5, 2005
PRODUCT

Bulk American Ginseng 550 mg Capsules containing 100% American Ginseng Powder (Panax quinquefolious), Bulk Product No. SW464, Nature¹s Value Bulk Lot # 035609. Product: American Ginseng Caps, Lot #: 035609, Date of Manufacture: 1/2004, P.O. #: 125541 and P.O. # 125229. 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. ---- NOTE: this bulk lot was repackaged into 100 capsule bottles by Swanson Health Products under its own label and sold to its retail customers under lot 127338 BG, Best before 01/06. Recall # F-109-5.
CODE Bulk Product No. SW464, Bulk Lot # 035609, Best Before 01/06.
RECALLING FIRM/MANUFACTURER Nature's Value Inc., Bay Shore, NY, by letters on October 18, 2004 and October 20, 2004. Firm initiated recall is ongoing.
REASON American Ginseng capsules were analyzed by the Northeast Regional Laboratory (NRL) and found to be contaminated with various pesticides.
VOLUME OF PRODUCT IN COMMERCE 149,000 capsules.
Distribution ND.

PRODUCT

a) Dietary supplement labeled in part:
NATURE**Sex. Plex for him***Directions:
As an adult supplement, for nutritional
support***30 Tablets. Recall $ F-118-5;
b) Dietary supplement labeled in part:
**Nature**Sex.Plex for her***Directions:
As an adult supplement, for nutritional
support30 Caplets**. Recall $ F-119-5;
c) Dietary supplement labeled in part: **Viga**
Supplements Facts***Serving Size 1 Tablet**
Saw Palmetto Extract 20mg* Androstenedione
10mg*Tribulus Terrestris Extract***
30 Tabletas*** Recall # F-120-5.
CODE a) Lot no. 02040096 Exp. date 04/2005;
b) Lot no. 02040097 Exp. date 4/2005;
c) Lot no. 04010010 Exp. date 01/2007.
RECALLING FIRM/MANUFACTURER Caribbean Nutraceuticals, Inc., Las Piedras, PR, by telephone and letter March 18, 2004 and April 27, 2004. Firm initiated recall is ongoing.
REASON The products are adulterated per 21 USC 342 (f) because they contain androstenedione, which is considered a new dietary ingredient.
VOLUME OF PRODUCT IN COMMERCE 22,542 bottles.
Distribution PR.
FDA Website: www.FDA.gov
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Last updated: 24 October 2007