IC-GREEN — Class III drug recall D-1429-2015
Terminated recall by Akorn, Inc., reported 2015-09-23, distributed nationwide. Subpotent Drug: Low out-of-specification potency result of the drug product.
| Recall number | D-1429-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2015-04-20 |
| Classified | 2015-09-11 |
| Reported by FDA | 2015-09-23 |
| Terminated | 2017-01-26 |
| Distributed | Nationwide (US) |
| Quantity | 370 kits |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00317478701255 |
| NDC | 17478-0701-02, 17478-0701-10, 17478-0701-25 |
| Lot numbers | 041514, 071374, 10/16 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1429-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.