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FDA Recalls (2002)

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U.S. Food & Drug Administration Actions: Recalls and Field Corrections Dietary Supplements -- 2002

  1. Acti-Gest tablets (labeled under numerous brands)
          —Spatz brand
          —Natural Products/ Natures Way brand
          —Full-O-Life brand -Edson Farms Natural Foods brand
          —Clark's Nutritional Centers brand
          —VP Health Food brand
          —Nature's Concept The Natural Choice brand 

  2. ARTHRIN Capsules, Joint and Tendon Formula
  3. BotaniCleanse(R) Natural Cleansing Supplement Botanical Concentrates
  4. Dalyvite Liquid, a Multi-vitamin Liquid distributed under the Hi-Tech label and Goldline label.
  5. Ferrous Sulfate Tablets, 325 mg. (Dietary Supplement) under the Eckerd, H.E.B., Longs, Nature's Valley, Sav-on Osco by Albertson's and Ultima labels
  6. Health Ade Solutomic Bio-Available Vitamins
  7. HEPASTAT capsules, Liver Formula
  8. Hsu & Co. Brand, Super Enzymes
  9. Metabolife Diet & Energy bar with special Nutrition Formula, Contains Inulin, Green Tea Extract. Including flavors:
           —Lemony Lemon, Yogurt Coated.
           —Downright Chocolate, Chocolate Flavor Coated.
           —Perfectly Peanut, Chocolate Flavor Coated
           —Outrageous Oatmeal Raisin, Yogurt Coated.

  10. Natural Oyster Shell Calcium 500 mg Tablets
  11. Nature's Plus(R) brand Complete Digestive Aid Digestive Enzyme Supplement
  12. Nature's Plus(R) brand Dietary Supplement Betaine Hydrochloride
  13. Nature's Plus(R) brand Maximum Strength Ultra-Zyme(R) Digestive Enzyme Supplement
  14. Nature's Plus(R) brand Nature Cleanse(R)
  15. Nature's Way Nettle Capsules
  16. NEUTRALIS Capsules, Immune System Formula
  17. OA PLUS Capsules, Joint and Tendon Formula
  18. OSPORO Capsules, Skeletal Formula
  19. PC SPES, Prostate Formula
  20. POENA Capsules, Muscle and Tissue Formula
  21. Prostatin Formula #103
  22. RASPES Capsules, Joint and Tendon Formula
  23. Solgar's Digestive Aid (US Label) and Solgar's Digestive Enzymes (UK Label)
  24. SP Natural Peanut Butter Standard Bar, Multi-Vitamin Whole Food Health Bar
  25. SPES Capsules, Immune System Formula
  26. Ultra Slim-Fast brand with Soy Protein Ready to Drink Liquid Shakes in 11.5 fl. oz. sizes:
            —Orange-Pineapple.
            —Apple-Cranberry-Raspberry.
            —Orange-Strawberry-Banana.


December 18, 2002
PRODUCT Natural Oyster Shell Calcium 500 mg Tablets in 100 count bottles. The product is shipped in cases that contain 72 of the 100 count bottles.
The brand name of the product is Kaiser Permanente. Recall # F-095-3.
CODE Lot #5235 exp. Jun 04.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Dixon Shane, Inc., Philadelphia, PA, by telephone on November 19, 2001.
Manufacturer: Vicen Nutritional, Swedesboro, NJ. Firm initiated recall is complete
REASON The product was manufactured under conditions whereby it may have been cross-contaminated with amoxicillin.
VOLUME OF PRODUCT IN COMMERCE 5436 bottles.
Distribution CA and OR.

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December 18, 2002
PRODUCT Health Ade Solutomic Bio-Available Vitamins in 1 quart bottles. Recall # F-102-3.
CODE 9315501 exp 12/01.
RECALLING
FIRM/MANUFACTURER
Eniva Corporation, Blaine, MN, by telephone beginning on July 20, 2001.
Firm initiated recall is complete.
REASON The product appeared to be spoiled (product was clumpy and bottles swollen).
VOLUME OF PRODUCT IN COMMERCE 1100 - 32 fluid ounce bottles.
Distribution Nationwide.
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August 7, 2002
PRODUCT RA SPES Capsules, Joint and Tendon Formula, 30 Capsules,
300 mg each, Herbal Dietary Supplement. Recall # D-363-2;

OA PLUS Capsules, Joint and Tendon Formula, 30 capsules, 300 mg each,
Herbal Dietary Supplement. Recall #. D-364-2;

HEPASTAT Capsules, Liver Formula, 90 capsules, 300 mg each,
Herbal Dietary Supplement.  Recall # D-365-2;

NEUTRALIS Capsules, Immune System Formula, 30 capsules, 300 mg each,
Herbal Dietary Supplement. Recall # D-366-2;

OSPORO Capsules, Skeletal Formula, 30 Capsules, 300 mg each,
Herbal Dietary Supplement. Recall # D-367-2;

POENA Capsules, Muscle and Tissue Formula, 30 capsules, 300 mg each,
Herbal Dietary Supplement. Recall # D-368-2;

ARTHRIN Capsules, Joint and Tendon Formula,
30 capsules, 300 mg each, Herbal Dietary Supplement. Recall # D-369-2.
CODE All codes.
RECALLING
FIRM/MANUFACTURER
Botanic Lab, Brea, CA, by letter on May 24, 2002. Firm initiated recall is ongoing.
REASON Products contain various amounts and combinations of undeclared prescription drug ingredients-Alprazolam, Indomethacin, Ethinyl Estradiol, and/or DES.
VOLUME OF PRODUCT IN COMMERCE Unknown.
Distribution Nationwide and Internationally.

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July 24, 2002
PRODUCT Nature's Way Nettle capsules, 100 count bottles.  Recall # F-651-2.
CODE Product Code 15150; Lots Numbers are 131237, 131238, 140738, and 215229.
RECALLING
FIRM/MANUFACTURER
Nature's Way Springville, UT, by letter on June 20, 2002.  Firm initiated recall is ongoing.
REASON Nettle capsules contain elevated amounts of lead.
VOLUME OF PRODUCT IN COMMERCE 40,409 /100 count bottles.
Distribution Nationwide and Canada, Jamaica, New Zealand, Panama, and Saudi Arabia.
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June 26, 2002
PRODUCT Dalyvite Liquid, a Multi-vitamin Liquid packed in brown, plastic bottles, One Pint (473 mL).
Product was distributed under the Hi-Tech label; Goldline label.  Recall # F-541-2.
CODE Lot 101624, expiration date 2/2003
Hi-Tech NDC 50383-624-16;
Goldline NDC 0182-6151-40.
RECALLING
FIRM/MANUFACTURER
Hi-Tech Pharmacal Co., Inc., Amityville, NY, by telephone and letter beginning March 7, 2002.  Firm initiated recall is ongoing.
REASON The product is contaminated with yeast, & complaints of swollen containers were received.
VOLUME OF PRODUCT IN COMMERCE 15,413 - 1 pint bottles.
Distribution NY, CA, IL, NC, KY, OH, PA, IN, NJ and Puerto Rico.
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May 29, 2002
PRODUCT SP Natural Peanut Butter Standard Bar, Multi-Vitamin Whole Food Health Bar, Net Wt 1.75 ounces. Recall # F-444-2.
CODE “Best Before Jul 26, 02,” “Best By Jul 31, 02” or “Best By Nov 20, 02” on the bar wrappers.  The recalled 18-bar boxes have batch numbers of 1299,1304, 0r 2051 on the bottom of the boxes.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Standard Process, Inc., Palmyra, WI, by letter on April 19, 2002.
Manufacturer:  Elan Nutrition (Formerly Five Star Brands) Grand Rapids, MI.  Firm initiated recall is ongoing.
REASON The labels do not list sesame seeds or extra virgin olive oil, which are contained in the product.
VOLUME OF PRODUCT IN COMMERCE 3362 boxes (18 bars each).
Distribution Nationwide.
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May 15, 2002
PRODUCT Ultra Slim-Fast brand with Soy Protein Ready to Drink Liquid Shakes in 11.5 fl. oz. sizes:
(a) Orange-Pineapple. Recall # F-397-2;
(b) Apple-Cranberry-Raspberry. Recall # F-398-2;
(c) Orange-Strawberry-Banana. Recall # F-399-2.
CODE “BEST BY” dates affected:
  JANUARY 2002
  FEBRUARY 2002
  MARCH 2002.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Slim-Fast Foods Co, (a Unilever Co.), West Palm Beach, FL,
by telephone, e-mail and fax beginning on February 13, 2001 and by letters
on February 14, 2001. Manufacturer: Kagome, Inc., Slim-Fast Foods Co., Los Banos, CA.
Firm initiated recall is complete.
REASON Products are contaminated with butyric acid anaerobes, resulting in sour taste and swollen cans.
VOLUME OF PRODUCT IN COMMERCE 13,896,864 cans.
Distribution Nationwide and Internationally.
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May 1, 2002
PRODUCT PC SPES, Prostate Formula, Herbal Dietary Supplement, 60 capsules, 320 mg each, over-the-counter sales.
Recall # D-198-2. Indicated for "prostate health" claim.
An herbal dietary supplement containing Chinese herbs (Reishi, Baikal Skullcap, Rabdosia, Dyer's Woad, Mum, Saw Palmetto, San-Qi Ginseng, Licorice).
CODE All lots and all codes.
RECALLING
FIRM/MANUFACTURER
International Medical Research, dba Botanic Labs Inc., Brea, CA, by letter dated February 8, 2002.  State initiated recall is ongoing.
REASON The product contains the undeclared prescription drug; Warfarin
VOLUME OF PRODUCT IN COMMERCE Unknown.
Distribution Nationwide and Internationally.
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March 6, 2002
PRODUCT SPES capsules, Herbal Dietary Supplement, Immune System Formula, 30 capsules per bottle, 300 mg each, containing 15 different herbs. 
Recall # D-196-2.
CODE Lot 5311214 distributed from 8/9/2001 to 1/8/2002;Lot 5431249 distributed from 10/25/2001 to 1/8/2002.
RECALLING
FIRM/MANUFACTURER
Botanic Lab Brea, CA, by letters on January 28, 2002. Firm initiated recall's ongoing.
REASON Product contains the undeclared prescription drug alprozolam.
VOLUME OF PRODUCT IN COMMERCE Undetermined
Distribution Nationwide and internationally.
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February 6, 2002

PRODUCT a) Hsu & Co. brand, Super Enzymes, 60 & 120 & 180 tablets,
Recall # F-280-2; b) Hsu & Co. brand, Super Enzymes, 60 & 180 capsules,
Recall # F-281-2;
c) Acti-Gest tablets (labeled under numerous brands)
   -Spatz brand, 90 tablets.
   -Natural Products/ Natures Way brand, 180 tablets.
   -Full-O-Life brand, 90 tablets.
   -Edson Farms Natural Foods brand, 90 & 180 tablets.
   -Clark's Nutritional Centers brand, 90 tablets.
   -VP Health Food brand, 90 & 180 tablets.
   -Nature's Concept The Natural Choice brand, 60 & 90 & 180 tablets. 
Recall # F-282-2.
CODE a) Lots 0050203 & 0090203;
b) Lots 0050203 & 0090203;
c) Lot 5800204;
   Lot 5800204;
   Lot 5800204;
   Lot 5800204;
   Lot 5800204;
   Lot 5800204;
   Lot 5800204.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Licata Enterprises, Huntington Beach, CA, by telephone and fax on May 16, 2001.
Manufacturer:  Horizon Laboratories, Chatsworth, CA.
Firm initiated recall is ongoing.
REASON Salmonella contamination of raw material Pepsin.
VOLUME OF PRODUCT IN COMMERCE 173,702 tablets, 95,008 capsules.
Distribution CA, OH and MI.
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January 30, 2002
PRODUCT Metabolife Diet & Energy bar with special Nutrition Formula, Contains Inulin, Green Tea Extract. 
Including flavors:
1) Lemony Lemon, Yogurt Coated.  Recall #F-144-2;
2) Downright Chocolate, Chocolate Flavor Coated.   Recall # F-145-2
3) Perfectly Peanut, Chocolate Flavor Coated.  Recall # F-146-2;
4) Outrageous Oatmeal Raisin, Yogurt Coated.  Recall # F-147-2. All bars are Net Weight 2 Oz. (56.8 g)
CODE Best buy dates 2/16/02 and earlier.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Metabolife International, San Diego, CA, on May 9, 2001 via press release followed by faxed letters and emails. Manufacturer:MLO Products Fairfield, CA. Firm initiated recall is complete.
REASON The products contained excessive amounts of Vitamin A.
VOLUME OF PRODUCT IN COMMERCE 4,917,216 bars.
Distribution Nationwide
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January 16, 2002

PRODUCT US Label:  Solgar's Digestive Aid, Dietary Supplement
UK Label: Solgar's Digestive Enzymes
Israeli Label: Solgar's Digestive Aid
French Label:  Solgar's Digestive Enzymes
Tablets packaged in plastic bottles of 100's.
Recall # F-114-2.
CODE Lot 31993 and 30957
RECALLING
FIRM/MANUFACTURER
Solgar Vitamin and Herb Leonia, NJ, by letter 4/25/01, FDA issued a press release on 4/27/01.  Firm initiated recall complete.
REASON The product was manufactured using pepsin that American Laboratories, Inc. recalled due to Salmonella contamination.
VOLUME OF PRODUCT IN COMMERCE 754 bottles
Distribution Nationwide and UK, South Africa, France, Ireland, and Israel.
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January 16, 2002
PRODUCT 1) Nature's Plus(R) brand Nature Cleanse(R)   BotaniCleanse(R) Natural Cleansing Supplement Botanical Concentrates, Green Foods & Vitamin C, 90 tablets per bottle, Product No. 1138;
 Recall # F-115-2;  
2) Nature's Plus(R) brand Complete Digestive Aid Digestive Enzyme Supplement, 90 tablets per bottle, Product No. 4450.
Recall # F-116-2;
3) Nature's Plus(R) brand Maximum Strength Ultra-Zyme(R) Digestive Enzyme Supplement The Ultimate Digestive Aid
     a) 90 tablets per bottle, Product No. 4452.
     b) 180 tablets per bottle, Product No. 4453.
     c) Italian label Nature's Plus(R) brand Enzimi Alimentari Ultra- Zyme(R)Bioalimento 90 Tavolette Peso netto 75g
Prodotto Numero E0 4452 01. Recall # F-117-2;
4) Nature's Plus(R) brand Dietary Supplement Betaine Hydrochloride 600 mg, 90 tablets per bottle, Product No. 4370.
  Recall # F-118-2.
CODE Firm on labels - Manufactured with LOVE by
Natural Organics Laboratories,Inc.,
makers of Nature's Plus Amityville,
New York U.S.A. NATURAL ORGANICS, Inc.(TM)Codes: 
   Product Name             Product #             Lot #s
Nature Cleanse                       1138              008597
BotaniCleanse         
Betaine Hydrochloride           4370             1006874
Digestive Enzyme                   4450             1008884
Ultra-Zyme 90 tabs                 4452             1007110
                                                                    1005942
                                                                    1009520
                                                                    1007562
Ultra-Zyme 180 tabs                4453            1005943
                                                                    1007116
                                                                    1009596
                                                                    1006906
Ultra-Zyme Bioalimento          4452 01       1009034
RECALLING
FIRM/MANUFACTURER
Recalling Firm:  Natural Organics, Inc. Melville, NY, by press release and letter on May 8, 2001,
Manufacturer:  Natural Organics Laboratories, Inc. Amityville, NY. 
FDA initiated recall is ongoing.
REASON The products were manufactured using pepsin that American Laboratories, Inc., recalled due to Salmonella contamination.
VOLUME OF PRODUCT IN COMMERCE BotaniCleanse: 1802 bottles; Digestive Enzyme:1461 bottles; Betaine HCl: 1771 bottles; Ultra-Zyme: 9626 bottles (90 tabs), 7446 (180 tabs), & 150 bottles (productto Italy).
Distribution Nationwide and International. The Ultra-Zyme Italian labeled product was sold to a sole distributor account in Italy.
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January 16, 2002
PRODUCT Ferrous Sulfate Tablets, 325 mg. (Dietary Supplement) under the Eckerd, H.E.B., Longs, Nature's Valley, Sav-on Osco by Albertson's and Ultima labels.  The product is packed in 60 and 100 tablet blister strips in a carton, Recall # F-120-2.
CODE Lot Numbers OD01649, OF02547, OMB0627, OM02553, OM03538, OD01649, OF02547, OH02400, 1CA2142, OH02400, OMB0628, OF02546, OMB1226, OKB1115, OMB0629.
RECALLING
FIRM/MANUFACTURER
Recalling Firm:  Leiner Health Products, Inc. Carson, CA, by letter on May 16, 2001. Manufacturer:  Leiner Health Products, Inc. Fort Mill, SC. Firm initiated recall is complete.
REASON The product is misbranded since it lists an incorrect tablet strength on the inner blister packs.
VOLUME OF PRODUCT IN COMMERCE 130,380 cartons.
Distribution Nationwide.
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January 9, 2002
PRODUCT Prostatin Formula #103, 500 mg capsules, 30 & 90 capsule bottles, Recall # F-110-2.
CODE All lots and codes.
RECALLING
FIRM/MANUFACTURER

Recalling Firm:  Herbal Doctor Remedies, Monterey Park, CA, by letter dated 03/07/01.
Manufacturer: Sheng Chang Pharmaceutical Co Ltd., Taipei Hsein, Taiwan.
Firm initiated recall is complete.

REASON

Product contains aristolochic acid, a potent carcinogen and nephrotoxin.

VOLUME OF PRODUCT IN COMMERCE 5/30 capsule and 2/90 capsule bottles only.
Distribution AZ, KY, PA and the Philippines.
FDA Website: www.FDA.gov
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Last updated: 24 October 2007