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SafetyAlerts
October 3, 2002

Ivax Pharmaceuticals Has Recalled Quinine Sulfate Tablets

(SafetyAlerts) - The Food and Drug Administration (FDA) has released the following information.

PRODUCT
Quinine Sulfate Tablets, USP, 260 mg, 100 count bottle, Rx only. Recall # D-413-2.

CODE
Lot No. Exp. date
3001-105631A Apr/04.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Ivax Pharmaceuticals, Inc., Miami, FL, by letter on August 29, 2002.
Manufacturer: Ivax Pharmaceutical Caribe, Inc., Cidra, Puerto Rico. Firm initiated recall is ongoing.

REASON
Tablet mixup; a bottle labeled as containing Quinine Sulfate tablets was found to contain Quinine Sulfate tablets and one tablet of Labetalol 100 mg, an antihypertensive.

VOLUME OF PRODUCT IN COMMERCE
12,000 bottles.

DISTRIBUTION
Nationwide.

 
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Health Professional:

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During 2000 there were over
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