December 28, 1999Ethex 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
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.
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