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SafetyAlerts
March 26, 2003

SmithKline Beecham Has Recalled AVODART Soft Gelatin Capsules

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


PRODUCT
AVODART Soft Gelatin Capsules, (dutasteride), 0.5 mg, unit dose pack, 70 capsules, 10 blistercard package containing 7 capsules each, Rx only. NDC 0173-0712-01. Recall # D-177-3.

CODE
Lot number RP 44904BB, Exp. Date SEP 30 2006.

RECALLING FIRM/MANUFACTURER
SmithKline Beecham, Corp., Zebulon, NC, by letters on February 11, 2003. Firm initiated recall is ongoing.

REASON
Mislabeled; blistercard labeling is incorrectly printed as "Sample-Not for Sale".

VOLUME OF PRODUCT IN COMMERCE
3,059 units.

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.