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January 18, 2000

Teva Pharmaceuticals Recalls Diltiazem Hydrochloride Extended Release Capsules

Sellersville, PA (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Teva Pharmaceuticals USA is recalling 120 mg Diltiazem Hydrochloride Extended Release Capsules because of dissolution failure at 3 months stability.

The recalled product, indicated for angina pectoris due to coronary artery spasms, was distributed in in 100-capsule bottles.  The product can be identified by the lot number 11829 and expiration date of 2/01.

According to FDA, only 9,500 bottles were distributed Nationwide.

This ongoing Class III recall was initiated by Teva Pharmaceuticals by letter on December 23, 1999.  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-200-0

Selected Recent Recalls

Health Professional:

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

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