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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
July 8, 1998

PRODUCT
Adult Low Strength Enteric Aspirin Tablets, 81 mg, OTC, in 120and 500 tablet bottles, under the following labels: Fay's, Goldline, Medicine Shoppe, Leader, and Fedco. Recall#D-187-8.

CODE
Fay's - Lot No. 6102858, 6103635, 7016164Goldline - Lot No. 6102662, 6114047Medicine Shoppe - Lot No. 6103519, 6114327, 6114424 Leader - Lot No. 6103654; Fedco - Lot No. 6103658.

MANUFACTURER
Granutec, Inc., Wilson, North Carolina.

RECALLED BY
Manufacturer, by telephone on May 20, 1998, and by letters mailedand faxed on May 22, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
82,104 120-count bottles and 4,326 500-count bottles weredistributed.

REASON
Lack of assurance product will meet potency throughout labeledexpiration date (assay/free salicylic acid).

 

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.