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.
D-1429-2015
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 71737
- Status
- Terminated
- Classification
- Class III
- Quantity
- 370 kits
- Official record key
drug-enforcement:D-1429-2015
Official wording
Reason: Subpotent Drug: Low out-of-specification potency result of the drug product.
Code information: Lot #: Kit: 071374; IC-Green: 041514, Exp 10/16
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent