FDA recall D-1429-2015

Akorn, Inc. · Class III · drug

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.

Reason for recall

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

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2015-04-20
Report date: 2015-09-23
Termination date: 2017-01-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1429-2015