October 24, 2002
Alpharma USHP Has Recalled Isosorbide
The Food and Drug
Administration (FDA) released the following information.
Isosorbide Mononitrate EXTENDED-RELEASE Tablets, 30 mg, 100 and 500 count
bottles, PUREPAC, Rx Only. Recall # D-035-3.
Recalling Firm: Alpharma USHP (formerly known as Purepac), Elizabeth, NJ, by
letter on July 18, 2002. Firm initiated recall is ongoing.
Dissolution Failure; 6 hour release (9 month stability).
VOLUME OF PRODUCT IN COMMERCE
105340 bottles of 100's; 11381 bottles of 500's.