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FDA Recalls & Court Actions: March 28, 1990

Executive Summary

CLASS II -- EPINEPHRINE MIST 1/2 ounce (15 cc) size, an OTC inhalation aerosol bronchodilator for the relief of bronchial asthma under the Barre-National, Eckerd Drug, Laverdiere's Super Drug, Longs Drug Stores, Peoples Drug Stores, Perry Distributing Inc., Pic N Save Drugs, Revco, Rite Aid, Rugby Labs Inc., Thrift Drug Company, Thrifty Corporation, and Walgreen Co. labels. Code: 82003, 82004, 82060, 82127, 82128, 82175, 82176, 82282, 82284, 82359, 82521, 82622, 82623, 82624, 82625, 92014, 92135, 92136, 92218, 92219, 92220, 92295, 92340, 92341. Manufacturer: Barre-National, Inc., Baltimore, Maryland. Recalled by: Manufacturer, by letters Dec. 4 and 8, 1989. Firm-initiated recall ongoing. Distribution: Nationwide. 1,126,392 units were distributed. Reason: Potency not assured through expiration date. CLASS II -- INDOMETHACIN CAPSULES, USP 25 mg and 50 mg, an Rx non-steroidal anti-inflammatory packaged in bottles of 100, 500 and 1,000 capsules under the Bioline, Goldline, Schein, and Superpharm labels. All lots. Manufacturer: Superpharm Corporation, Bayshore, New York. Recalled by: Manufacturer, by letter Feb. 1, 1990. Firm-initiated recall ongoing. Distribution: New York, California, Connecticut, Florida, Ohio, Texas. 4,200,000/25 ml bottles and 1,700,000/50 ml bottles were distributed. Reason: Lack of assurance of bioequivalency and Abbreviated New Drug Application discrepancies. CLASS II -- OTC ANTACID ORAL SUSPENSION With 200 mg magnesium hydroxide and 225 mg aluminum hydroxide in 12 ounce bottles, used for the relief of heart burn, acid indigestion, sour stomach and upset stomach, under the Geneva Generics and RIJ Pharmaceutical labels. Lot #90609. Manufacturer: RIJ Pharmaceutical Corporation, Chester, New York. Recalled by: Manufacturer, by telephone Feb. 7, 1990. Firm- initiated recall ongoing. Distribution: Tennessee, Georgia, Massachusetts, Rhode Island. Firm estimates less than 1 percent remains on market. Reason: Bacterial contamination. CLASS II -- TRIAMTERENE/HYDROCHLOROTHIAZIDE TABLETS 75 mg/50 mg, in bottles of 100, 500, and 1,000, an Rx diuretic used for the treatment of hypertension, under the American Therapeutics, Best Generics, Bioline Laboratories, Goldline Laboratories, Harbor Pharmaceutical and Kaiser Foundation Hospital labels. Lot No.: 805134 exp. 5/90; Lot No.: 812380, exp. 12/90; Lot No.: 810288, exp. 10/90; Lot No.: 812381, exp. 12/90; Lot No.: 810289, exp. 10/90; Lot No.: 812388, exp. 12/90; Lot No.: 811326, exp. 11/90; Lot No.: 901031, exp. 1/91; Lot No.: 812359, exp. 12/90; Lot No.: 901032, exp. 1/91; Lot No.: 812360, exp. 12/90; Lot No.: 903062, exp. 3/91; Lot No.: 812361, exp. 12/90; Lot No.: 903063, exp. 3/91; Lot No.: 812362, exp. 12/90; Lot No.: 903064, exp. 3/91. Manufacturer: American Therapeutucs, Inc., Bohemia, New York. Recalled by: Manufacturer, by letter Feb. 6-8, 1990. Firm-initiated recall ongoing. Distribution: California, Connecticut, Florida, Georgia, Kentucky, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Virginia. 16 lots each consisting of 1,000,000 tablets were distributed; firm estimates 1.6 million tablets remain on the market. Reason: Product failed dissolution testing. CLASS III -- INSULIN AND SODIUM CHLORIDE INJECTION, USP In 50 ml vials, an Rx drug administered intravenously as a sterile, non-pyrogenic solution and used as a diagnostic agent to measure kidney glomerular filtration. Lot 58803 EXP 3/90. Manufacturer: Taylor Pharmacal Company, Decatur, Illinois. Recalled by: Iso-Tex Diagnostics, Inc., Friendswood, Texas, by telephone Feb. 20-21, 1990. Firm-initiated recall ongoing. Distribution: Nationwide, Canada. 2,059 vials were distributed; firm estimates 240 vials remain on market. Reason: Free fructose exceeds USP limit. CLASS III -- LARIAM (MEFLOQUINE HYDROCHLORIDE) TABLETS 250 mg, in unit dose aluminum foil strips in cartons containing 25 tablets, a newly approved Rx antimalarial agent. Code: 0001 EXP 9/1/92. Manufacturer: F. Hoffmann-LaRoche & Co., Ltd., Basle, Switzerland. Recalled by: Roche Laboratories, Nutley, New Jersey, by telephone Feb. 28, 1990 and March 1-2, 1990 followed by letter March 3 and 6, 1990. Firm-initiated recall ongoing. Distribution: Nationwide. 1,859 (25 unit dose foil packs each) were distributed. Reason: Packaging defect -- Some unit dose blisters contain two tablets instead of one tablet. CLASS III -- MOISTUREL CREAM In 4 ounce and 16 ounce jars, an OTC drug to be applied to the skin for generalized dry skin. Lot numbers 95A011 through 95A056 and 95B001 through 95B046. Manufacturer: Westwood Pharmaceuticals, Inc., Buffalo, New York. Recalled by: Manufacturer, by telephone Jan. 30, 1990 followed by letter. Firm-initiated recall ongoing. Distribution: Nationwide. 549,036 jars were distributed; firm estimates 60,000 jars remain on market. Reason: Preservative system may not be effective during use of product.
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