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.
Indocyanine Green
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Indocyanine Green (P.F.), 15 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Drug: Indocyanine
- Recalling firm
- Wells Pharmacy Network LLC
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0362-2017 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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 III · Low risk
IC-Green (indocyanine green for injection, USP)
Product is being recalled due to low pH value.
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 Wells Pharmacy Network LLC
All 2016 recalls
Class II · Moderate risk
Testosterone Cypionate in Sesame Oil Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone Cypionate in Grapeseed Oil Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin D3 in Sesame Oil Injectable 50
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin D3 in Sesame Oil Injectable 100
Lack of Assurance of Sterility
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