January 27, 2000Mutual 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
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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