Novartis Pharmaceuticals Has Recalled Combipatch Transdermal System

[Wendy]

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

PRODUCT
Combipatch Transdermal System, (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day, 3 Patient Calendar Packs of 8 Systems, Rx only. Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey Recall # D-304-3.

CODE
Lot Number: 61921011, Expiry 06-2004.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Novartis Pharmaceuticals, Corp, Suffern, NY, by letter on July 3, 2003.
Manufactured by: Noven Pharmaceuticals, Inc., Miami, Florida. Firm initiated recall is ongoing.

REASON
Subpotency (estradiol/NETA) and Degradation failure (excess primary estradiol degradant).

VOLUME OF PRODUCT IN COMMERCE
256,608 patches.

DISTRIBUTION
Nationwide.