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Updated February 15

Geneva Pharmaceuticals, Inc. Recalls Naproxen Tablets

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

The recalled prescription was distributed in 500 mg strength, in 100, 500 and 1,000 tablet bottles and can be identified as follows:

NDC#  0781-1165-10 (1000 tablet bottles)
Lot Number 106583, expiration date 04/02

NDC#  0781-1165-05 ( 500 tablet bottles)
Lot Number 106584, expiration date 04/02

NDC#  0781-1165-01 ( 100 tablet bottles)
Lot Number 106585, expiration date 05/02

NDC#  0781-1165-10 (1000 tablet bottles)
Lot Number 106585, expiration date 05/02

NDC#  0781-1165-05 ( 500 tablet bottles)
Lot Number 105921, expiration date 04/02

NDC#  0781-1165-05 ( 500 tablet bottles)
Lot Number 106119, expiration date 04/02.

New Codes Added 2/15/00

NDC#  0781-1165-10 (1000 tablet bottles)
Lot Number 105841, expiration date 04/02

NDC#  0781-1165-10 (1000 tablet bottles)
Lot Number 106208, expiration date 04/02

NDC#  0781-1165-10 (1000 tablet bottles)
Lot Number 106209, expiration date 04/02

NDC#  0781-1165-01 (100 tablet bottles)
Lot Number 106234, expiration date 04/02

NDC#  0781-1165-13 (UD)
Lot Number 106234, expiration date 04/01

NDC#  0781-1165-05 (500 tablet bottles)
Lot Number 106235, expiration date 04/02

NDC#  0781-1165-13 (UD)
Lot Number 106442, expiration date 04/01

NDC#  0781-1165-10 (1000 tablet bottles)
Lot Number 106442, expiration date 04/02

NDC#  0781-1165-10 (1000 tablet bottles)
Lot Number 106512, expiration date 04/02

NDC#  0781-1165-05 (500 tablet bottles)
Lot Number 106753, expiration date 05/02

NDC#  0781-1165-05 (500 tablet bottles)
Lot Number 106754, expiration date 05/02

NDC#  0781-1165-10 (1000 tablet bottles)
Lot Number 106755, expiration date 05/02

NDC#  0781-1165-05 (500 tablet bottles)
Lot Number 106980, expiration date 05/02

NDC#  0781-1165-01 (100 tablet bottles)
Lot Number 107145, expiration date 05/02

NDC#  0781-1165-10 (1000 tablet bottles)
Lot Number 107146, expiration date 05/02

NDC#  0781-1165-10 (1000 tablet bottles)
Lot Number 107245, expiration date 05/02

NDC#  0781-1165-05 (500 tablet bottles)
Lot Number 107246, expiration date 05/02

NDC#  0781-1165-01 (100 tablet bottles)
Lot Number 107354, expiration date 05/02

NDC#  0781-1165-10 (1000 tablet bottles)
Lot Number 107355, expiration date 05/02

According to FDA, over 8,200,000 units were distributed nationwide.

This ongoing Class II recall was initiated by Geneva by letter on December 17, 1999.  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-202-0

 
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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