Alpharma USHP Has Recalled Isosorbide Mononitrate

(This medicine is a vasodilator used to prevent angina (chest pain).

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

PRODUCT
Isosorbide Mononitrate EXTENDED-RELEASE Tablets, 30 mg, 100 and 500 count bottles, PUREPAC, Rx Only. Recall # D-035-3.

CODE

Lots Exp.
135E1 7/2003
136E1 7/2003
137E1 7/2003
138E1 7/2003
139E1 7/2003
140E1 7/2003
173F1 8/2003.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Alpharma USHP (formerly known as Purepac), Elizabeth, NJ, by letter on July 18, 2002. Firm initiated recall is ongoing.

REASON
Dissolution Failure; 6 hour release (9 month stability).

VOLUME OF PRODUCT IN COMMERCE
105340 bottles of 100's; 11381 bottles of 500's.

DISTRIBUTION
Nationwide.