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SafetyAlerts
February 7, 2003

Ivax Pharmaceuticals Has Recalled Fluoxetine Capsules

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

PRODUCT
Fluoxetine Capsules USP, 20 mg, 500 and 1000 count bottles,
Rx only. Recall # D-061-3.

CODE
Lot 105458, Exp. 2/2004, 500 Count---NDC #00172-4356-70
Lot 104926, Exp. 2/2004, 1000 Count--NDC #00172-4356-80.

RECALLING FIRM/MANUFACTURER
Ivax Pharmaceuticals, Northvale, NJ, by letters on July 16, 2002. Firm initiated recall is ongoing.

REASON
Product exceeded specification for impurity level (1 month stability).

VOLUME OF PRODUCT IN COMMERCE
2991 bottles.

DISTRIBUTION
Nationwide and Puerto Rico.

 

 
Selected Recent Recalls


Health Professional:

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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.