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SafetyAlerts
November 5,  2003

Akorn Has Recalled Sufenta Injection

(SafetyAlerts) - The FDA has released the following information.

PRODUCT
Sufenta Injection, (Sufentanil Citrate), 50 mcg/mL (Sufentanil base),1 mL and 5 mL ampules, 10 ampules per carton; Rx Only. Recall # D-030-4.

CODE
Lot Number-1 mL ampule, 11522, Exp. 1/4 and 5 mL ampule, 11192, Exp. 01/04.

RECALLING FIRM/MANUFACTURER
Akorn, Inc., Decatur, IL by letter dated September 12, 2003. Firm initiated recall is ongoing.

REASON
Unapproved New Drug; These lots were manufactured with an active ingredient produced according to a drug master file method not cited in the approved New Drug Application.

VOLUME OF PRODUCT IN COMMERCE
24,460 ampules.

DISTRIBUTION
Nationwide and Puerto Rico
.

 
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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.