Alpharma Purepac Has Recalled Diltiazem CD Capsules

(SafetyAlerts) - The Food and Drug Administration (FDA) has released the following information.


PRODUCT
Diltiazem CD Capsules (Diltiazem hydrochloride Extended-Release Capsules, USP) 180 mg, 90 capsule bottles, (Once-a-Day Dosage), Rx only. Recall # D-194-3;

CODE
Lot 725D21 Exp 3/04;
Lot 726D21 Exp 3/04;
Lot 727D31 Exp 3/04;
Lot 728D21 Exp 1/04.

RECALLING FIRM/MANUFACTURER
Alpharma Purepac, Elizabeth, NJ, by letter on February 5, 2003. Firm initiated recall is ongoing.

REASON
Failure to validate a reduced batch size manufacturing process.

VOLUME OF PRODUCT IN COMMERCE
33,005 bottles.

DISTRIBUTION
Nationwide.