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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
March 24, 1999

PRODUCT
Mapap Tablets, Regular Strength (Acetaminophen) 325 mg, in 1000tablet bottles, OTC labeled as an aspirin free pain reliever,distributed by Major Pharmaceuticals. NDC #0904-1982-80.Recall #D-145-9.

CODE
Lot #98M422 EXP 12/01.

MANUFACTURER
PDK Laboratories, Inc., Hauppauge, New York.

RECALLED BY
Manufacturer, by letters faxed on February 18, 1999, and mailedon February 23, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Indiana and California.

QUANTITY
2,797 bottles were distributed; firm estimated that 1,327 bottlesremained on market at time of recall initiation.

REASON
Tablet mix-up - Some acetaminophen 500 mg tablets were mixed inbottles of 325 mg tablets.

 

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.