Akorn Inc recalls Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured by…

Recall date

April 23, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1241-2019

FDA classification

Class III

Brand / firm

Akorn Inc

Sold / distributed

U.S.A. Nationwide

Why it was recalled

Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-25