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 I
Recalled September 23, 2015 · FDA recall D-1429-2015 · Akorn
Hazard
Subpotent Drug: Low out-of-specification potency result of the drug product. · FDA Class III
Units
370 kits
Sold at
Nationwide
Description
Subpotent Drug: Low out-of-specification potency result of the drug product.
Product
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.
Manufacturer(s)
Akorn, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →