May 2, 2002
Purepac Pharmaceuticals Lovastatin Tablets
- The Food and Drug Administration (FDA) released the following information.
Lovastatin Tablets, USP, 20mg, bottle of 60 tablets,
NDC #0228-2634-06, Rx Only. Recall # D-243-2.
Lots 220F11, Exp. 6/03
221F11, Exp. 6/03.
Purepac Pharmaceuticals, Elizabeth, NJ, by letters on February 25, 2002.
Firm initiated recall is complete.
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 .