SafetyAlerts
February 7, 2003
Ivax Pharmaceuticals Has Recalled
Fluoxetine Capsules
(Fluoxetine Capsules is a Prozac
generic.)
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.
