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RECALLS & COURT ACTIONS: Oct. 28 & Nov. 4, 1992

Executive Summary

CLASS III -- ACNE DAY LOTION An OTC drug packaged in 2 ounce and 16 ounce containers, a non-PABA sunscreen. Recall number: D-050-3. Lot number 2786. Manufacturer: Chemolee Labs, Inc., Irving, Texas. Recalled by: Manufacturer, by telephone Aug. 1, 1992. Firm-initiated recall ongoing. Distribution: California; Firm estimates none remains on the market. Reason: Presence of mold. CLASS III -- PAT DUER DIURETIC TABLETS An herbal product, in plastic bottles of 90 and 250 tablets. Recall number: D-049-3. Code 103792 EXP 12/93. Manufacturer: Fibertone/Patten, also known as Naturally Vitamin supplements, Scottsdale, Arizona. Recalled by: Manufacturer, by letter Aug. 14, 1992. Firm-initiated recall ongoing. Distribution: California, Illinois, Oregon, Texas, Utah, Washington state; 37 bottles of 90 tablets each and 37 bottles of 250 tablets each were distributed. Reason: Current good manufacturing practice deficiencies. SEIZURES -- CALCIUM PANGAMATE TABLETS (92-607-526). Charge: Adulterated -- The product contains the food additive, N, N-dimethylglycine, which is unsafe because there is no regulation in effect prescribing the conditions under which the additive may be safely used. Firm: General Nutrition Corporation, Inc., Leetsdale, Pennsylvania. Filed: June 5, 1992 -- U.S. District Court for the Western District of Pennsylvania; Civil number 92-1388; FDC number 66377. Seized: June 29, 1992 -- goods valued at approximately $3,775. SEIZURES -- NOLATRIM-75 PHENYLPROPANOLAMINE HYDROCHLORIDE TIMED RELEASE CAPSULES (92-630-655). Charge: Adulterated -- The methods used in, and the facilities and controls used for, the product's manufacture, processing, and holding do not conform to and are not operated and administered in conformity with current good manufacturing practice regulations. Misbranded -- The product's label fails to contain the correct place of business of the distributor. Firm: Wesley Pharmacal Company, Ivyland, Pennsylvania. Filed: Sept. 22, 1992; U.S. District Court for the Eastern District of Pennsylvania; Civil number 92CV5491; FDC number 66601. Seized: Sept. 28, 1992 -- 93 bottles, valued at approximately $2,697.
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