April 5, 2000Copley 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.
Safety Alerts compiles
comprehensive safety recall information for the United States. SafeMail is a free email
service to warn consumers of faulty products and contaminated foods. For complete
information regarding current recalls, past recalls and timely product warning
notification visit: www.safetyalerts.com.