Class III
Terminated
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.
- Company
- Akorn, Inc.
- Recall Initiated
- April 20, 2015
- Posted
- September 23, 2015
- Recall Number
- D-1429-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 370 kits
- Firm Location
- Lake Forest, IL, United States
Reason for Recall
Subpotent Drug: Low out-of-specification potency result of the drug product.
Distribution
Nationwide
Lot / Code Info
Lot #: Kit: 071374; IC-Green: 041514, Exp 10/16
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