Recalls Procainamide Hydrochloride Extended Release Tablets
August 4, 1999
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
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
b) Procanbid(tm) Tablets, Extended-Release, 1000 mg, in 60 tablet
a) Lot #795D6D EXP 10/99, N0071-0562-20 Lot #797D6D EXP 10/99,
b) Lot #33137D EXP 02/00, N0071-0564-20.
Warner-Lambert Company, Morris Plains, New Jersey.
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.
a) 44,098 bottles;
b) 10,592 bottles were distributed;
firm estimated that minimal amount of product remained on market at time of recall