FDA RECALLS & COURT ACTIONS: Feb. 3, 1993
CLASS II (a) BEN-AQUA 5 WASH, BENZOYL PEROXIDE, USP 5% A therapeutic cleanser for the control of acne, in 5 fluid ounce plastic cylinder; (b) Ben-Aqua 10 wash, Benzoyl Peroxide, USP, 10% a therapeutic cleanser for the control of acne, in 5 fluid ounce plastic cylinder. Recall number: D-104/105-3. Lot numbers: (a) H516 EXP 6/94; (b) H517 EXP 6/94. Manufacturer: Syosset Laboratories Company, Syosset, New York. Recalled by: Manufacturer, by letter January 8, 1993. Firm- initiated recall ongoing. Distribution: California, Texas, Connecticut, Virginia, Colorado. (a) 1,205 containers were distributed; firm estimates 90 percent remains on the market; (b) 1,470 containers were distributed; firm estimates 90 percent remains on the market. Reason: Potential for microbial contamination. CLASS II - LITE-COAT ASPIRIN TABLETS 325 mg, in bottles of 100, 110, 250, 300 and 500, under the following labels: Bradlees, Freddy's Good Health, Legend, Medic, Phar-Mor, Pic N Save, Seaway, Shop N Save, Stop N Shop, Sweetlife, Thayer, Wegmans. Recall number: D-109-3. Lot numbers: K1005E, K1006E, K1007E, L1006E. Manufacturer: Pennex Products Company, Inc., Verona, Pennsylvania. Recalled by: Manufacturer, by letter July 22, 1992. Firm-initiated recall ongoing. Distribution: Nationwide. 16,351,920 bottles were distributed. Reason: Possible presence of metal particles. CLASS II - QUALITY VALUE BRAND ORAL ANALGESIC ASPIRIN 1-1/4 gr, in 1,000 tablet bottles. Recall number: D-107-3. Lot numbers: 7878. Manufacturer: LNK International, Hauppauge, New York. Recalled By: Manufacturer, by telephone on or about May 15, 1992. Firm-initiated field correction ongoing. Distribution: Virginia. 300 bottles were distributed. Reason: Absence of some dosage directions and lack of conspicuousness of specific caution statements. CLASS II - RIFADIN CAPSULES 300 mg, a Rx drug used to treat tuberculosis and asymptomatic carriers of N. meningitides, in bottles containing 30, 60 and 100 capsules. Recall number: D-106-3. 30 count bottles - 8461YD, 9442YL, 9461YM, 9670AB, and 9884AD; 60 count bottles - 8458YD, 8459YD, 8779YF, 9108YH, 9109YH, 9110YH, 9415YH, 9246YL, 9247YL, 9459YM, 9460YM, 9667AB, 9668AB, 9669AB, 9841AD, and 9842AD; 100 count bottles - 8455YD, 8456YD, 8745YF, 9106YH, 9107YH, 9245YL, 9378YL, 9500YM, 9726YN, 9501YM, 9540AB, 9541AB, 9760AD and 0110AF. Manufacturer: Marion Merrell Dow, Inc., Cincinnati, Ohio. Recalled by: Manufacturer, by telephone during the week of 1/11/93, followed by letter dated January 4, 1993. Firm-initiated recall ongoing. Distribution: Nationwide. 62,168 of the 100 count bottles; 118,737 of the 60 count bottles; and 63,932 of the 30 count bottles were distributed. Reason: Product does not meet dissolution specifications. CLASS III BETATAR GEL SHAMPOO In 8 fluid ounce bottles and 1 fluid ounce bottles (professional sample), therapeutic shampoo for dandruff and seborrheic dermatitis. Recall number: D-108-3. Lot number: GKA. Manufacturer: Jewett Manufacturing Corporation, San Antonio, Texas. Recalled by: Beta Dermaceuticals, Inc., San Antonio, Texas, by telephone January 6, 1993. Firm-initiated recall ongoing. Distribution: Louisiana, Texas. 120 8-fluid ounce bottles and 144 1-fluid ounce bottles were distributed. Reason: Formulation not in compliance for dandruff and dermatitis products. CLASS III - BULK FENTANYL CITRATE USP In 17 gram glass bottles, a bulk drug powder. Recall number: D-111-3. Lot number: 0662SHL003. Manufacturer: Mallinckrodt Specialty Chemicals, St. Louis, Missouri. Recalled by: Manufacturer, by letter December 11, 1992. Firm-initiated recall ongoing. Distribution: Massachusetts. 17 grams were distributed. Reason: Use of manufacturing method not currently approved. CLASS II - CVS BRAND TIMED RELEASE COLD & ALLERGY TABLETS 15 mg brompheniramine and 75 mg phenylpropanolamine HCl packaged 12 tablets per carton, an OTC product. Recall number: D-110-3. Lot numbers: D6073E, J6003E, J6078E. Manufacturer: Pennex Products Company, Inc., Verona, Pennsylvania. Recalled by: Manufacturer, by telephone July 14, 1992, followed by letter July 14, 1992. Firm-initiated recall ongoing. Distribution: Nationwide. 2,449 dozen of lot D6073E, 2,336 dozen of lot J6003E, 57 dozen of lot J60783. Reason: Front label panel incorrectly declares ingredients as 25 mg each. Rear panel correctly states 12 mg and 75 mg.
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