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SafetyAlerts
April 2, 2003

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.

 

 
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Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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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.