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Safety Alerts
August 4, 1999

Parke-Davis Recalls Procainamide Hydrochloride Extended Release Tablets

Morris Plains, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that The Parke-Davis Division of Warner-Lambert Company is recalling Procainamide Hydrochloride Extended Release Tablets because of dissolution failure.

PRODUCT
Procainamide Hydrochloride Extended Release Tablets, Rx products indicated for use as an anti-arrhythmic:
a) Procanbid(tm) Tablets Extended-Release , 500 mg, in 60 tablet bottles;
b) Procanbid(tm) Tablets, Extended-Release, 1000 mg, in 60 tablet bottles.

Recall #D-295/296-9.

CODE
a) Lot #795D6D EXP 10/99, N0071-0562-20 Lot #797D6D EXP 10/99, N0071-0562-20;
b) Lot #33137D EXP 02/00, N0071-0564-20.

MANUFACTURER
Warner-Lambert Company, Morris Plains, New Jersey.

RECALLED BY
The Parke-Davis Division of Warner-Lambert Company, Morris Plains, New Jersey, a) by letter mailed on April 16, 1999; by letters mailed on November 11, 1998 and April 30, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
a) 44,098 bottles;
b) 10,592 bottles were distributed;
firm estimated that minimal amount of product remained on market at time of recall initiation.

 

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.