Recalls / Class III
Class IIID-0697-2017
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
- Affected lot / code info
- Kit Lot #031126; Exp 8/2018
Why it was recalled
Product is being recalled due to low pH value.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 1,292 kits
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-04-20
- FDA classified
- 2017-05-09
- Posted by FDA
- 2017-05-17
- Terminated
- 2019-02-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0697-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.