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November 30, 1999

Roche Laboratories Klonopin Tablets Recalled

Nutley, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Roche Laboratories is recalling Klonopin Tablets because impurity level exceeds specification.

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

This recall affects all lots of:
a) Klonopin (Clonazepam) tablets, 0.5 mg, 25 and 100 tablet units:
b) Klonopin (Clonazepam) tablets, 1 mg, 25 and 100 tablet units;
c) Klonopin (Clonazepam) Tablets, 2 mg, 25 and 100 tablet units.
that have the NDC numbers of 0004-0068-01, 0004-0068-50, 0004-0058-01, 0004-0058-50, 0004-0098-01 and 0004-0098-50.

Over 48,706 pieces were distributed nationwide.

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

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.