D-1429-2015 Class III Terminated
FDA drug recall D-1429-2015 was initiated by Akorn, Inc. on Apr 20, 2015 and is designated Class III. Reason for recall: Subpotent Drug: Low out-of-specification potency result of the drug product. The recall status is terminated (terminated Jan 26, 2017). Affected quantity: 370 kits.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 23, 2015
- Initiation Date
- Apr 20, 2015
- Termination Date
- Jan 26, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 370 kits
Product Description
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 Pattern
Nationwide
Code Information
Lot #: Kit: 071374; IC-Green: 041514, Exp 10/16
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1429-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026