FDA Recalls IC-Green Injectable Drug: Manufacturing Deviations Prevent Stability Verification
Akorn, Inc. recalled all lots of IC-Green injectable drug nationwide because the firm went out of business and could not complete stability studies required to verify manufacturing compliance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of an injectable drug with manufacturing deviations and incomplete stability studies. No illnesses or injuries have been reported, but this represents a risk-of-harm product where patient safety cannot be verified due to incomplete stability data.
Plain-English summary
Akorn, Inc. is recalling all lots of IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit nationwide and in Puerto Rico. The recall was issued because the manufacturer experienced CGMP (Current Good Manufacturing Practice) deviations and, after going out of business, could no longer continue the stability studies required to demonstrate that the product meets manufacturing and safety standards.
IC-Green is an injectable diagnostic dye used in medical imaging procedures. The inability to complete stability studies means the manufacturer cannot verify that the product maintains its safety and effectiveness throughout its shelf life.
Healthcare providers and patients using this product should consult with their healthcare provider about the recall. The FDA and the recalling firm are working to ensure affected product is removed from distribution.
The recalled product
- Product
- 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
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Injectable / Diagnostic
- Hazard
- cgmp-deviation
- stability-study-incomplete
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Distributed nationwide across the United States.
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