Clonazepam Recall - August 02

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Teva Has Recalled Clonazepam Tablets

(Also known as Klonopin. Used in treatment as an anti-convulsant, also used for treatment of panic attacks, restless leg syndrome and other psychiatric conditions.)

August 14, 2002 Safety Alerts

The Food and Drug Administration (FDA) has released the following information.

PRODUCT
a) Clonazepam Tablets, USP 1 mg, 100, 500, and 1,000 count bottles, Rx only. Recall # D-372-2;
b) Clonazepam Tablets, USP 2 mg, 100 and 500 count bottles, Rx only. Recall # D-373-2.

CODE
a) Lot numbers for 1 mg strength:
356546 exp. 11/30/03, 356547 exp. 11/30/03, 356548 exp. 11/30/03, 356549 exp. 11/30/03, 356550 exp. 11/30/03, 356551 exp. 11/30/03, 356552 exp. 11/30/03, 356553 exp. 11/30/03, 356554 exp. 11/30/03, 356555 exp. 11/30/03, 356556 exp. 11/30/03, 356557 exp. 11/30/03, 356558 exp. 11/30/03, 356559 exp. 11/30/03, 356560 exp. 11/30/03, 356561 exp. 11/30/03, 356562 exp. 11/30/03, 356563 exp. 11/30/03, 356564 exp. 11/30/03, and 356565 exp. 11/30/03.
b) Lot numbers for 2 mg strength:
355108 exp. 11/30/03, 355109 exp. 11/30/03, and
355110 exp. 11/30/03.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Sellersville, PA, by letters on June 10, 2002.
Manufacturer: Teva Pharmaceuticals, Jerusalem, Israel.
Firm initiated recall is ongoing.

REASON
Tablet mix up: 2 mg tablets may be in bottles labeled as containing 1 mg tablets and/or 1 mg tablets may be in bottles labeled as containing 2mg tablets.

VOLUME OF PRODUCT IN COMMERCE
160,391 bottles.

DISTRIBUTION
Nationwide.