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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
June 9, 1999

Park Davis Recalls Dilantin 30 mg Kapseals

Morris Plains, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Park Davis, Division of Warner Lambert Company, is recalling Dilantin 30 mg Kapseals because of dissolution failure (at 3 month stability testing).

This is the first public notice issued by the FDA.

PRODUCT
Dilantin 30 mg Kapseals (Extended Phenytoin Sodium Capsules, USP), in bottles of 100. NDC N0071-0365-24.

CODE
Lot #27458L EXP 6/00.

MANUFACTURER
Warner Lambert Company, Morris Plains, New Jersey.

RECALLED BY
Park Davis, Division of Warner Lambert Company, Morris Plains, New Jersey, by letter dated February 17, 1999. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
36,376 units were distributed.

Recall #D-232-9.

 

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.