Class II · Moderate risk
IC-Green (indocyanine green for injection, USP)
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
IC-Green (indocyanine green for injection, USP)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Product is being recalled due to low pH value.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
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 NDC
17478-0701-02
Compare with the code on your package — it is the most precise check available.
Drug: Indocyanine
- Recalling firm
- Akorn, Inc.
- NDC code
- 17478-701-02
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0697-2017 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Indocyanine recalls
See all
Class II · Moderate risk
Indocyanine Green
Lack of Assurance of Sterility
Class II · Moderate risk
Fluorescein/Indocyanine
Lack of Assurance of Sterility
Class III · Low risk
IC-GREEN (indocyanine green for injection, USP)
Subpotent Drug: Low out-of-specification potency result of the drug product.
Class II · Moderate risk
Indocyanine Green active pharmaceutical ingredient packaged in…
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.
Other recalls by Akorn, Inc.
All 2017 recalls
Class II · Moderate risk
Tropicamide Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Ropivacaine Hydrochloride Injection USP
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Pilocarpine Hydrochloride Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Pilocarpine Hydrochloride Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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