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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
September 16, 1998

PRODUCT
Extra Strength Acetaminophen Tablets, 500 mg, OTC, in 60 and 100 tablet bottles, under the Family Pharmacy and Fred's label. Recall #D-236-8.

CODE
Lot numbers: 8032215 and 8064485.

MANUFACTURER
Granutec, Inc., Wilson, North Carolina.

RECALLED BY
Manufacturer, by telephone on August 7, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
1,441 units of Fred's 60-count and 1,875 units of Family Pharmacy 100-count bottles were distributed.

REASON
Tablet mix-up - Aspirin and caffeine tablets were commingled with these lots during packaging.

 

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.