|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
March 25, 1998
Procainamide Hydrochloride Extended Release
Tablets, USP, 500 mg, in 100 tablet bottles,
indicated for treatment of documented arrhythmias,
under the Schein Pharmaceutical label.
Lot #D6A0205 EXP 2/98
Danbury Pharmacal, Inc., a subsidiary of Schein
Pharmaceutical, Danbury, Connecticut.
Manufacturer, by letter faxed on March 2, 1998.
Firm-initiated recall ongoing.
Alabama, Arizona, California, Georgia, Idaho,
Illinois, Ohio, Massachusetts, Minnesota, New
Mexico, New Jersey, Pennsylvania, Tennessee,
Kentucky, Virginia, Indiana, West Virginia.
1,955 bottles were distributed.
Dissolution failure at 4th hour interval (24 month