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SafetyAlerts
October 24, 2002

Alpharma USHP Has Recalled Isosorbide Mononitrate

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

PRODUCT
Isosorbide Mononitrate EXTENDED-RELEASE Tablets, 30 mg, 100 and 500 count bottles, PUREPAC, Rx Only. Recall # D-035-3.

CODE


Lots Exp.
135E1 7/2003
136E1 7/2003
137E1 7/2003
138E1 7/2003
139E1 7/2003
140E1 7/2003
173F1 8/2003.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Alpharma USHP (formerly known as Purepac), Elizabeth, NJ, by letter on July 18, 2002. Firm initiated recall is ongoing.

REASON
Dissolution Failure; 6 hour release (9 month stability).

VOLUME OF PRODUCT IN COMMERCE
105340 bottles of 100's; 11381 bottles of 500's.

DISTRIBUTION
Nationwide.

 
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Health Professional:

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During 2000 there were over
1050 products recalled in the United
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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.