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February 15, 2000

Geneva Pharmaceuticals, Inc. Recalls Naproxen Tablets

Broomfield, CO (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Geneva Pharmaceuticals, Inc. is recalling certain Naproxen Tablets because of metal wire/particle contamination.

The recalled Naproxen Tablets (USP, Rx), in stengnths of 250 mg - in 100, 500, 1,000-tablet bottles and in stengnths of 375 mg, in 500-tablet bottles was distributed nationwide.

According to FDA, 12 million tablets are affected by this recall and can be identified by the following codes:

NDC# 0781-1163-13 -(UD), Lot# 106404, EXP 04/01
NDC# 0781-1163-10 -(1000's), Lot# 106404, EXP 04/02
NDC# 0781-1163-01 -(100's), Lot# 106405, EXP 04/02
NDC# 0781-1163-05 -(500's), Lot# 106405, EXP 04/02
NDC# 0781-1163-10 -(1000's), Lot# 107022, EXP 05/02
NDC# 0781-1163-01 -(100's), Lot# 107153, EXP 05/02
NDC# 0781-1163-10 -(1000's), Lot# 107153, EXP 05/02
NDC# 0781-1163-01 -(100's), Lot# 107553, EXP 06/02
NDC# 0781-1163-10 -(1000's), Lot# 107553, EXP 06/02
NDC# 0781-1164-05 -(500's), Lot# 106249, EXP 04/02

This ongoing Class II recall was initiated by Geneva Pharmaceuticals by letter on January 21, 2000.  This is the first public notice issued by the FDA.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #D-213/214-0

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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