Class II · Moderate risk Ongoing
IC-Green
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Ic-Green
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug: Low out-of-specification potency result of the drug product.
What was recalled
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.
- Recalling firm
- Akorn, Inc.
- NDC code
- 17478-701-02
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1429-2015
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Indocyanine recalls
See all
Class III · Low risk Terminated
IC-Green
Reason Product is being recalled due to low pH value.
Class II · Moderate risk Terminated
Indocyanine Green
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Fluorescein/Indocyanine
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Indocyanine Green active pharmaceutical ingredient packaged in…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
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