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SafetyAlerts
November 27, 2002

Teva Pharmaceuticals Has Recalled Etodolac Extended-Release Tablets

(Etodolac is indicated for acute and long-term use in the management of osteoarthritis and pain.)

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

PRODUCT
Etodolac Extended-Release Tablets, 500 mg, 100 count bottles, Rx only. Recall # D-059-3.

CODE
Lot number 502044 exp. 2/04.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA Inc., North Wales, PA, by letters dated October 23, 2002.
Manufacturer: Teva Pharmaceuticals USA Inc., Jerusalem, Israel. Firm initiated recall is ongoing.

REASON
Tablet mixup; a bottle labeled to contain Etodolac Extended-Release tablets was found to contain both Etodolac Extended-Release tablets and one tablet of Tramadol HCl 50 mg

VOLUME OF PRODUCT IN COMMERCE
4084 bottles.

DISTRIBUTION
Nationwide.

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November 28, 2002
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