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December 14, 1999

Roche Laboratories Recalls Klonopin Tablets

Nutley, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Roche Laboratories is recalling Klonopin Tablets, a brand of Clonazepam used in the treatment of seizure disorders, because the product had the incorrect expiration date on label.

This ongoing Class III recall was initiated by the company, by telephone on September 3, 1999, followed by letter. This is the first notice the FDA has issued to the general public of the recall.

The recalled product was distributed in bottles of 100 tablets in the following strengths:
0.5 mg, NDC `0004-0068-01
1.0 mgm, NDC #0004-0058-01
2.0 mg, NDC #0004-0098-01

These products bear the lot numbers and expiration dates of U0003 11/2000, U0004 11/2000, U0501 12/2000, U0502 12/2000 or U1002 11/2000

Over 79,000 units were distributed nationwide.

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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