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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
September 2, 1998

PRODUCT
Amway brand "FORMUCARE" Triple Antibiotic Ointment (Bacitracin-Neomycin Sulfate-Polymyxin B Sulfate), net wt. 28.35 g (1 oz.). An OTC topical antibiotic used for first aid. Manufactured for Amway Corporation, Ada, MI. Recall #D-230-8.

CODE
Lot M255, expiration date 1/2000 Lot M211, expiration date 12/1999

Amway product codes: Triple antibiotic ointment A-5600; Antifungal Cream A-5569.

MANUFACTURER
Thames Pharmacal Co., Inc., Ronkonkoma, New York.

RECALLED BY
Manufacturer, by verbal direction to distributer on May 18, 1998 and by letter August 3, 1998. Firm-initiated recall on-going.

DISTRIBUTION
Amway Coporation, East Ada, Michigan.

QUANTITY
1,308.5 cases were distributed.

REASON
Mispackaging - some tubes of Amway brand "FORMUCARE" Antifungal Cream were packaged into cartons labeled "Formucare" Triple Antibiotic Ointment and distributed.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.