Drug product
IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit containing six vials of 25 mg lyophilized powder, Rx only, Manufactured by: Akorn, Inc., NDC 17478-701-02
D-0697-2017
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 77071
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,292 kits
- Official record key
drug-enforcement:D-0697-2017
Official wording
Reason: Product is being recalled due to low pH value.
Code information: Kit Lot #031126; Exp 8/2018
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Product is being recalled due to low pH value.