Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA RECALLS & COURT ACTIONS: Feb. 3, 1993

Executive Summary

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.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS022122

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel