December 14, 1999Roche Laboratories Recalls
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
Over 79,000 units were distributed
Questions concerning this recall may
be directed to the FDA at 1-888-INFO-FDA.
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