IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
8 FDA recalls mention Indocyanine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Indocyanine.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Product is being recalled due to low pH value.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Subpotent Drug: Low out-of-specification potency result of the drug product.
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…
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because…
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because…
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