FDA recall D-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

Reason for recall

Product is being recalled due to low pH value.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-04-20

Report date

2017-05-17

Termination date

2019-02-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0697-2017