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April 5, 2000

Copley Pharmaceutical Inc. Recalls Diltiazem Hydrochloride Tablets

Brooklyn, NY (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Copley Pharmaceutical Inc. is recalling Diltiazem Hydrochloride Tablets because of dissolution failure (stability).

The Diltiazem Hydrochloride Tablets, USP, in 60 mg bottles of 100 and 500, are a prescription indicated for the management of chronic stable angina and angina due to coronary artery spasm.

According to the FDA, approximately 3,500 bottles were distributed Nationwide. The recalled bottles bear the lot number of  662F01, EXP 5/00.

This ongoing Class III recall was initiated by Copley Pharmaceutical Inc., by letter on March 13, 2000.  This is the first public notice issued by the FDA.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #d-256-0

Notice of this product warning was sent via email to SafeMail subscribers April 5, 2000.

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