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December 28, 1999

Ethex Disopyramide Phosphate Extended-Release Capsules Recalled

St. Louis, MO (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Ethex Corporation is recalling Ethex Disopyramide Phosphate Extended-Release Capsules because of dissolution failure (6 month stability-12th hour).

This ongoing Class II recall was initiated by the company by letter dated November 9, 1999.  This is the first public notice issued by the FDA.

Ethex Disopyramide Phosphate Extended-Release Capsules, USP, 150 mg, in 100 capsule bottles are a prescription for the treatment of documented ventricular arrhythmias. The recalled capsules (NDC #58177-002-04) bear the Lot # L14596 EXP 3/29/02.  Over 6,000 bottles were distributed Nationwide.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

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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