Class III · Low risk Terminated
IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit containing six vials of 25 mg lyophilized powder, Rx…
Reason Product is being recalled due to low pH value.
IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Sterile…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
What was recalled
IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
- Recalling firm
- Akorn, Inc.
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0812-2023
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 II · Moderate risk Terminated
Indocyanine Green (P.F.), 15 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Fluorescein/Indocyanine, Lyophilized (P.F.), 400 mg/15 mg, 1 mL, Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
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…
Reason Subpotent Drug: Low out-of-specification potency result of the drug product.
Class II · Moderate risk Terminated
Indocyanine Green active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184…
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…
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