November 5, 2003
Akorn Has Recalled Sufenta Injection
The FDA has released the following information.
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.
Lot Number-1 mL ampule, 11522, Exp. 1/4 and 5 mL ampule, 11192, Exp. 01/04.
Akorn, Inc., Decatur, IL by letter dated September 12, 2003. Firm initiated
recall is ongoing.
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
Nationwide and Puerto Rico.