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SafetyAlerts
February 7, 2003

Eon Labs Manufacturing Has Recalled Nabumetone Tablets

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

PRODUCT
a) Nabumetone Tablets, 500 mg, 100 count bottles, Rx only,
NDC 0185-0145-01. Recall # D-065-3;
b) Nabumetone Tablets, 750 mg, 100 count bottles, Rx only,
NDC 0185-0146-01. Recall # D-066-3.

CODE
a) and b) Lot 021159, expiration date 10/2004.

RECALLING FIRM/MANUFACTURER
Eon Labs Manufacturing Inc., Laurelton, NY, by letter and fax on November 13, 2002. Firm initiated recall is ongoing.

REASON
Mislabeling - some bottles labeled to contain Nabumetone 750 mg tablets actually contain Nabumetone 500 mg tablets.

VOLUME OF PRODUCT IN COMMERCE
1533 bottles total lot.

DISTRIBUTION
Nationwide.

 

 
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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.