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SafetyAlerts
February 7, 2003

Bristol-Myers Squibb Has Recalled MEGACE tablets

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

PRODUCT
a) MEGACE tablets (megestrol acetate, USP), 20 mg,100 count
bottles, Rx Only. Recall # D-114-3;
b) MEGACE tablets (megestrol acetate, USP), 40 mg, 100
count bottles, Rx Only. Recall # D-115-3.

CODE
a) Megace 20 mg TABLETS

Lot no. Exp. date
OB31296 1/2003
1A42693 1/2004
1D47119 5/2004
1L55188 10/2004

b) Megace 40 mg TABLETS

Lot no. Exp. date
1B37102 1/2004
1F39749 5/2004
1D47154 5/2004
1J56964 5/2004
1D47155 6/2004
1L55181 10/2004
2H56553 10/2004
1L55141 11/2004
1L55142 11/2004
2H56552 8/2004

RECALLING FIRM/MANUFACTURER
Bristol-Myers Squibb Company, New Brunswick, NJ, by letters on November 5, 2002. Firm initiated recall is ongoing.

REASON
Dissolution Failure; tablets are below specification.

VOLUME OF PRODUCT IN COMMERCE
44,779 bottles (20 and 40 mg).

DISTRIBUTION
United States and the following countries Buenos Aires, Argentina, Seoul, Korea, Rep. Of South Africa, Santiago, Chile, Phillipines, and Vietnam.

 

 
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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.