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January 27, 2000

Mutual Pharmaceutical Co. Recalls Quinidine Gluconate Extended Release Tablets

Philadelphia, PA (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Mutual Pharmaceutical Co. is recalling Quinidine Gluconate Extended Release Tablets because of dissolution failure (12 month stability 8 hours time point).

The recalled product, USP, 324 mg, in 100-tablet bottles, a prescription for conversion of atrial fibrillation/flutter; reduction of frequency of relapse into atrial fibrillation/flutter; and suppression of ventricular arrhythmias has NDC #53489-141-01.  The product can be identified by the lot number of #39239 - EXP 8/01

According to FDA, 5,836 bottles were distributed nationwide.

This ongoing Class III recall was initiated by Mutual Pharmaceutical Co. by letter dated January 10, 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-207-0

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Health Professional:

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During 2000 there were over
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