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December 14, 1999

Watson Laboratories Recalls Norco Tablets

Corona, CA (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Watson Laboratories is recalling Norco Tablets 10mg/325 mg Hydrocodone Bitartrate/ Acetaminophen because the labeling lacks approval.

This ongoing Class III recall was initiated by the company, by letter on October 14, 1999. This is the first notice the FDA has issued to the general public of the recall.

The recalled product, NDC #52544-539-30, bears the lot numbers and expiration dates of:

53902R96F 11/1998
53903R96F 11/1998
53901R96F 11/1998
53904R96F 11/1998
53904J98F 09/2000
53903M98F 10/2000
53910M98F 10/2000
53901R98F 11/2000
53904R98F 11/2000
53901A99F 01/2001
53902A99F 01/2001
53903A99F 01/2001
53904A99F 01/2001
53901C99F 03/2001.

Over 222,000 cartons were distributed nationwide as Physician Samples. Each cartons contains 15 units of 2 tablets and is prescribed for the relief of moderate to moderately severe pain.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

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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