Recalls / Class III
Class IIID-1429-2015
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.
- Affected lot / code info
- Lot #: Kit: 071374; IC-Green: 041514, Exp 10/16
Why it was recalled
Subpotent Drug: Low out-of-specification potency result of the drug product.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W. Field Court, Suite 300, Lake Forest, Illinois 60045
Distribution
- Quantity
- 370 kits
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-04-20
- FDA classified
- 2015-09-11
- Posted by FDA
- 2015-09-23
- Terminated
- 2017-01-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1429-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.