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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
March 25, 1998

PRODUCT
Procainamide Hydrochloride Extended Release
Tablets, USP, 500 mg, in 100 tablet bottles,
indicated for treatment of documented arrhythmias,
under the Schein Pharmaceutical label.
NDC #0364-0716-01.

Recall #D-107-8.

CODE

Lot #D6A0205 EXP 2/98

MANUFACTURER

Danbury Pharmacal, Inc., a subsidiary of Schein
Pharmaceutical, Danbury, Connecticut.

RECALLED BY

Manufacturer, by letter faxed on March 2, 1998.
Firm-initiated recall ongoing.

DISTRIBUTION

Alabama, Arizona, California, Georgia, Idaho,
Illinois, Ohio, Massachusetts, Minnesota, New
Mexico, New Jersey, Pennsylvania, Tennessee,
Kentucky, Virginia, Indiana, West Virginia.

QUANTITY

1,955 bottles were distributed.

REASON

Dissolution failure at 4th hour interval (24 month
stability test).

 

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.