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Posted January 18, 2002

Recall of Pepsin-containing Digestive Supplements

The U.S. Food and Drug Administration (FDA) released the following Class I recall information in its January 16, 2002 Enforcement Report. A Class I recall is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death:

Two Products Recalled:

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. [Note from Several other brands of digestive-aid products containing pepsin were recalled inn 2001.]


DISTRIBUTION Nationwide and UK, South Africa, France, Ireland, and Israel.

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 4452 01 1009034 Bioalimento

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 (product to Italy).

DISTRIBUTION Nationwide and International. The Ultra-Zyme Italian labeled product was sold to a sole distributor account in Italy