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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