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FDA RECALLS & COURT ACTIONS: Sept. 2, 1992

Executive Summary

CLASS II -- CLINDAMYCIN HYDROCHLORIDE U.S. A Rx drug, used for the treatment of bacterial infection. Recall number: D-472-2. Lot number "EC110." Manufacturer: Abbott Laboratories, North Chicago, Illinois. Recalled by: Spectrum Chemical Manufacture Corporation (repacker/responsible firm), Gardena, California by telephone June 8 and letter June 15, 1992. Firm-initiated recall ongoing. Distribution: North Carolina, Massachusetts; 1 X 1 gram and 1 X 100 gram bottles were distributed. Reason: Repacked from bulk material after the expiration date. CLASS II -- XERO-LUBE SALIVA SUBSTITUTE An OTC drug for the relief of dry mouth (xerostomia) in 6 fl. oz. plastic bottles, Recall number: D-470-2. Lot number 20345, exp. date 4/95. Manufacturer: Colgate Hoyt/Gel-Kam, Dallas, Texas. Recalled by: Colgate Hoyt/Gel-Kam, Canton, Massachusetts by letter May 13, 1992. Firm-initiated recall ongoing. Distribution: California, Ohio, Texas; 10,461 bottles were distributed. Reason: Presence of Pseudomonas aeruginosa. CLASS III -- BEN AQUA 10% GEL (Benzoyl Peroxide Gel, USP, 10%) in 1.5 oz. tubes, an Rx drug used in the treatment of acne. Recall number: D-466-2. Lot number H283, exp. date 12/93. Manufacturer: Syosset Laboratories Company, Inc., Syosset, New York. Recalled by: Manufacturer by telephone June 1992 and letter dated July 2, 1992. Firm initiated recall ongoing. Distribution: Nationwide, Puerto Rico; 6,377 tubes were distributed. Reason: Some tubes have labels stating potency as 5%. The carton correctly declares 10% potency. CLASS III -- "EXCEL" 0.9% SODIUM CHLORIDE INJECTION USP In 500 ml plastic containers, used for treatment of metabolic alkalosis in the presence of fluid loss, and mild sodium depletion. Recall number: D-469-2. Lot numbers: J2B600, J2B740, J2C629, J2E552, J2B608, J2B622 ,J2B627, J2B645, J2B670, J2B673, J2B684, J2B688, J2B705, J2B736, J2C502, J2C505, J2C549, J2C553, J2C558, J2C561, J2C591, J2C607, J2C611, J2C626, J2C672, J2C676, J2C691, J2C694, J2C709, J2C713, J2C726, J2C729, J2C742, J2C747, J2E597, J2E600, J2E644, J2E649, J2E653, J2E660, J2E668, J2E671, J2E716. Manufacturer: McGaw, Inc., Irvine, California. Recalled by: Manufacturer by letter July 27, 1992. Firm-initiated recall ongoing. Distribution: Nationwide, Saudi Arabia, Venezuela, Puerto Rico; 29,481 cases were distributed. Reason: Some units developed leakage under use conditions involving pressurization. CLASS III -- HYDROCORTISONE CREAM, USP, 0.5% WITH ALOE VERA GEL In 1 ounce and 2 oz. tubes. Recall number: D-468-2 Lot numbers G658, G659, G660 exp. date 8/92; H149 exp. date 8/93; H330 exp. date 2/94. Manufacturer: Syosset Laboratories Company, Inc., Syosset, New York. Recalled by: Manufacturer by telephone during the week of July 27- 31, 1992. Firm initiated recall ongoing. Distribution: New York, Florida, Michigan, Illinois; 14,377 units were distributed. Reason: Ingredient statement on label incorrectly indicates 50 mg hydrocortisone per gram, when product has potency of 0.5%. Preservative listed in ingredient statement is incorrectly listed as 2-Bromo-2-Nitropropane-1,3 Diol. The preservative actually used in all these recalled lots is Imidazolidinyl Urea. Recalled product was also distributed under another label for lot number G659. This label has correct amount of active ingredient hydrocortisone (5 mg/gram). Aloe Vera Gel is not listed on label and this product does contain Aloe Vera Gel. CLASS III -- KENALOG CREAM, .025% TRIAMCINOLONE ACETONIDE 15 gram and 80 gram tubes, an Rx drug, used for the relief of the inflammatory and pruritic manifestations. Recall number: D-471-2. Lot number 1A31752 (15 gram), exp. date 1/1/92, 1A31763 (80 gram), exp. 1/1/93. Manufacturer: Westwood Squibb Pharmaceuticals, Inc., Buffalo, New York. Recalled by: Bristol-Myers Squibb, Humacoa, Puerto Rico by letter Aug. 20, 1992. Firm-initiated recall ongoing. Distribution: Nationwide; 791 cases of (15 gram), 10,080 cases of (80 gram) were distributed. Reason: Subpotency. CLASS III -- MULTI VIT DROPS In 50 ml bottles, an OTC product used for the supplementation of the diet for essential vitamins. Recall number: F-489-2. Lot numbers 03463, exp. date 7/92; 03890, exp. date 1/93; I3367, exp. date 7/93. Manufacturer: Barre National, Inc., Baltimore, Maryland. Recalled by: Manufacturer by letter on or about July 27, 1992. Firm initiated recall ongoing. Distribution: Nationwide; 53,341 bottles were distributed. Firm estimates 3,903 bottles remain on market. Reason: Product fails to meet stability specifications and is deficient in Vitamin B12. CLASS III -- NIACIN TABLETS 500 mg, 100 per bottle. Recall number: F-492-2. Lot number 1217-CL- 100 or R816. Manufacturer: Custom Label Corporation of America, Mountlake Terrace, Washington. Recalled by: Manufacturer by telephone Sept. 5, 1991. Firm-initiated recall complete. Distribution: Nationwide; 314 bottles were distributed. Reason: Product was misbranded as Sustained Release Niacin Tablets. CLASS III -- SYOXIN, ACETONE BASE GEL (Benzoyl Peroxide Gel, USP 20%) net wt. 1.5 oz., an Rx drug. Recall number: D-467-2. Lot number H427, exp. date 4/94. Manufacturer: Syosset Laboratories Company, Inc., Syosset, New York. Recalled by: Manufacturer by letter July 31, 1992. Firm initiated recall ongoing. Distribution: Nationwide, Mexico; 9,944 units were distributed. Reason: Some tubes have leakage at the crimp end. CLASS III UPDATE -- TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX), EXTENDED-RELEASE SUSPENSION Tussionex Pennkinetic (Hydrocodone Polistirex and Chlorpheniramine Polistirex), Extended-Release Suspension. Recall number: D-447, which appeared in the Aug. 12, 1992 Enforcement Report ("The Pink Sheet" Aug. 17, T&G-12) should read: Manufacturer: Fisons Corporation, Rochester New York instead of American Crystal Sugar, Moorehead, Minnesota.
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