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SafetyAlerts
March 05, 2003

Akorn Has Recalled Drugs

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

PRODUCT
a) Fluoracaine, Fluorescein Sodium and Proparacaine
Hydrochloride Ophthalmic Solution USP, Sterile, Rx Only,
Active : Fluorescein Sodium 0.25%, Proparacaine
Hydrochloride 0.5% ; 5 mL glass screw cap vial with
black propylene cap and sterile dropper.
Recall # D-155-3;
b) Fluress, Fluorescein Sodium and Benoxinate Hydrochloride
Ophthalmic Solution USP; Sterile , Active: Fluorescein
Sodium 0.25%, Benoxinate Hydrochloride 0.4%, 5 mL glass
screw cap vial with black propylene cap and sterile
dropper. Recall # D-156-3.

CODE
a) Lot numbers 31061, exp. 3/03; 51121, exp. 5/03; 81051,
exp. 8/03; 11302, exp. 1/04; 51222, exp. 5/04, NDC #
17478-311-10;
b) Lot numbers 81211, exp. 2/03; 91181, exp. 3/03; 121271,
exp. 6/03; 11392, exp. 7/03; 21042, exp. 8/03; 21052,
exp. 8/03; 41422, exp. 10/03; 51062, exp. 11/03.

RECALLING FIRM/MANUFACTURER
Akorn, Inc., Decatur, IL, by letter dated January 14, 2003. Firm
initiated recall ongoing.

REASON
Container/closure integrity problems; leaking containers.

VOLUME OF PRODUCT IN COMMERCE
a) 129,594 bottles;
b) 222,400 bottles.

DISTRIBUTION
Nationwide, Bahamas, Israel, the Phillipines, Canada and Australia.

 

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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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.