Akorn, Inc. recalls IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02, UPC 3 17478-701-02 6) containing 6-count…

Recall date

April 20, 2015

Source

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

Recall number

D-1429-2015

FDA classification

Class III

Brand / firm

Akorn, Inc.

Sold / distributed

Nationwide

Why it was recalled

Subpotent Drug: Low out-of-specification potency result of the drug product.

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

What was recalled

IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02, UPC 3 17478-701-02 6) containing 6-count IC-Green Vials 25 mg (NDC 17478-701-25, barcode (01)00317478701255) and 6-count 10 mL Sterile Aqueous Solvent Ampules (NDC 17478-701-10, UPC 3 17478-701-10 1) per carton, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.