Metformin Hydrochloride Tablets Recall

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SafetyAlerts
April 2, 2003

Alpharma Purepac Has Recalled Acyclovir Tablets & Metformin Hydrochloride Tablets

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

PRODUCT
a) Acyclovir Tablets, USP, 400 mg, 100 tablet bottles,
Rx only. Recall # D-192-3;
b) Metformin Hydrochloride Tablets, 1000 mg, 500 tablet
bottles, Rx only. Recall # D-193-3;

CODE
a) Lot 553C21 Exp. 4/04;
b) Lot 438F21 Exp. 7/04.

RECALLING FIRM/MANUFACTURER
Alpharma Purepac, Elizabeth, NJ, by letter on February 5, 2003. Firm initiated recall is ongoing.

REASON
a) Tablets contain fibers;
b) Product may contain iron/zinc particles.

VOLUME OF PRODUCT IN COMMERCE
a) 16,482 bottles;
b) 1,970 bottles;
c) 33,005 bottles.

DISTRIBUTION
Nationwide.