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October 18, 2001

Taro Pharmaceutical Recalls Etodolac Capsules

Hawthorne, NY (SafetyAlerts) - The Food and Drug Administration (FDA) said that Taro Pharmaceuticals U.S.A., Inc. is recalling Etodolac Capsules, USP, 200 mg, Rx only, 100 Capsule bottles.

This is the first public notice of this Class llI recall issued by the FDA.

RECALL NUMBER, PRODUCT AND CODE:
D-310-1, Etodolac Capsules, USP, 200 mg, Rx only, 100 Capsule bottles, NDC 51672-4016-1,

Codes:
Lot 014430, expiration date 5/2003, NDC 51672-4016-1, ANDA #75-078.

REASON:
Misbranded: Product label incorrectly declares product as tablets.

MANUFACTURER:
Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel,

RECALLED BY:
Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY, via letter on 9/13/2001

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
PA and KY

QUANTITY:
1582 bottles (100s).

 
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Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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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.