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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

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

PRODUCT
Maxalt Tablets (Rizatriptan Benzoate), 10 mg, in complimentary (physician) sample cartons, Rx. Recall #D-238-8.

CODE
Lot #H0602 EXP 3/00.

MANUFACTURER
Merck Manufacturing Division, Division of Merck & Company, West Point, Pennsylvania.

RECALLED BY
Manufacturer, by letter on August 3, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
7,256 units were distributed.

REASON
Mislabeling - Some cartons contain individual foil packages which are printed with the incorrect product strength 5 mg while the tablets are actually 10 mg.

 

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.