FDA Drug recall D-1429-2015
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…
- FDA Drug
- Class III
- terminated
- Published 2015-09-23
On 2015-09-23 the FDA classified a Class III recall of 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… by Akorn, citing subpotent Drug: Low out-of-specification potency result of the drug product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1429-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-04-20 |
| Published | 2015-09-23 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Akorn |
| Distribution | US |
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
Subpotent Drug: Low out-of-specification potency result of the drug product.
Identifiers
| upc | 317478701026 |
|---|---|
| upc | 317478701101 |
| code_info | Lot #: Kit: 071374; IC-Green: 041514, Exp 10/16 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1429-2015%22
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