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SafetyAlerts
June 25, 2003

Akorn Has Recalled Drugs

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

PRODUCT
a) Methylene Blue Injection, USP, 1%, lmL, 10 vials per
carton, Rx only. Recall # D-251-3;
b) Myochrysine, Gold Sodium Thiomalate Injection, USP,
50 mg/mL, 1 mL Single Dose Vials and 10 mL Multiple Dose
Vials, Rx only. Recall # D-252-3;
c) Edex Diluent, (bacteriostatic 0.9% sodium chloride
injection preserved with benzyl alcohol 0.945% w/v),
1.2mL syringe, Rx Only. Recall # D-253-3;
d) Sarapin Injection, 50 mL vials. Recall # D-254-3.

CODE
a) Lot 21192, Exp 2/04;
b) Lot 41092, Exp 4 (mL vial) Lots 41082, Exp 4/04 (10mL
vial) and Lot 51242, Exp 5/04 (10mL vial);
c) Lots 61062, 121232;
d) Lots 31272, 41132, 51312.

RECALLING FIRM/MANUFACTURER
Akorn, Inc., Decatur, IL, by letters on April 3, 2003. Firm initiated recall is ongoing.

REASON
Lack of assurance of sterility.

VOLUME OF PRODUCT IN COMMERCE
a) 20,582 vials;
b) 19,168 vials;
c) not supplied;
d) 50,667 vials;

DISTRIBUTION
Nationwide.

 
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.