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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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