The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0812-2023·Announced 2023-06-07

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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

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.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 86 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 86 products in this recall →

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