Nabumetone Tablet Recall

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SafetyAlerts
February 7, 2003

Eon Labs Manufacturing Has Recalled Nabumetone Tablets

(Nabumetone Tablets are a Relafen Generic a non- steroidal anti-inflamatory medication.)

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.