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.
Reported: September 23, 2015 Initiated: April 20, 2015 #D-1429-2015
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.
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 370 kits
- Distribution
- Nationwide
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Akorn, Inc.. Units affected: 370 kits.
Why was this product recalled? ▼
Subpotent Drug: Low out-of-specification potency result of the drug product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 23, 2015. Severity: Low. Recall number: D-1429-2015.
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