Purepac Pharmaceuticals Lovastatin Tablets Recall Update

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

PRODUCT
Lovastatin Tablets, USP, 20mg, bottle of 60 tablets,
NDC #0228-2634-06, Rx Only. Recall # D-243-2.

CODE
Lots 220F11, Exp. 6/03
221F11, Exp. 6/03.

RECALLING FIRM/MANUFACTURER
Purepac Pharmaceuticals, Elizabeth, NJ, by letters on February 25, 2002. Firm initiated recall is complete.

REASON
Product failed stability requirement for impurity level.

VOLUME OF PRODUCT IN COMMERCE
Lot 220F11 -- 826,080 tablets as 13,768/60 count bottles;
Lot 221F11 -- 848,820 tablets as 14,147/60 count bottles .

DISTRIBUTION
Nationwide.