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SafetyAlerts
May 21, 2003

 

Teva Pharmaceuticals Has Recalled Enalapril Maleate Tablets

(
Antihypertensive, generic equivalent of Vasotec)

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

PRODUCT
Enalapril Maleate Tablets, USP, 10 mg, bottles of 1000, TEVA, Rx only. Recall # D-247-3.

CODE
Lot # 15741 exp 5/31/03.

RECALLING FIRM/MANUFACTURER
Teva Pharmaceuticals USA, North Wales, PA, by letters dated March 19, 2003. Firm initiated recall is
ongoing.

REASON
Degradation: Related compound specification failure (18 month stability).

VOLUME OF PRODUCT IN COMMERCE
1,182 bottles.

DISTRIBUTION
Nationwide.
 

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