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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

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

PRODUCT
Aspirin Tablets, USP, Chewable, Orange Flavored, 81 mg(1-1/4 grain), in 100 tablets (10 x 10 blister cards), NDC #62584-645-01, and 750 tablets (25 x 30 blister cards), NDC #62584-645-33. Recall #D-135-9.

CODE
Lot numbers: 4363C, 5542B, 6191A, 6192A, 8034B, 8716B, 4363B,5542A, 6191B, 6192B, 6192C, 8034A, 8276, 8716A, and 9315.

MANUFACTURER
LNK International, Inc, Hauppauge, New York.

RECALLED BY
AmeriSource Health Services Corporation, doing business asAmerican Health Packaging, Columbus, Ohio (repacker/responsible firm), by letter on March 2, 1999. Firm-initiated recallongoing.

DISTRIBUTION
Texas, Idaho, Kentucky, Florida, Arizona, Massachusetts, NewJersey, Wisconsin, Pennsylvania, Virginia, Indiana, Oklahoma, NewYork, Illinois.

QUANTITY
881 units of 25 blister cards X 30 tablets, and 27,558 units of10 blister cards X 10 tablets were distributed; firm estimated that 654 units (25 X 30) and 20,874 units (10 X 10) remained indistribution channels at time of recall initiation.

REASON
Stability - Out of specification for percent (%) 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.