Akorn recalls all IC-Green 25 mg/10 mL kits due to inability to complete stability studies after the company went out of business.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling all 25 mg/10 mL IC-Green kits because the manufacturer went out of business and can no longer complete stability testing. This means the product may not be safe for use as the company no longer has the resources to ensure its quality.
The manufacturer went out of business and could no longer conduct stability studies. This means the product's safety and effectiveness cannot be confirmed, but it does not indicate immediate danger to users.
Prescription drug users who have the IC-Green 25 mg/10 mL kit. Patients who received this medication from a healthcare provider are most at risk.
Check for the IC-Green 25 mg/10 mL kit with the manufacturer's address in Lake Forest, IL. All lots and all National Drug Codes (NDCs) are affected.
Review the product label for the IC-Green 25 mg/10 mL kit with the manufacturer's address in Lake Forest, IL.
The recall states the manufacturer went out of business and cannot complete stability studies, so safety cannot be confirmed.
The recall does not specify a stop-use instruction, but the product may not be safe due to the lack of stability testing.
The recall record does not mention any replacement options or remedies.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0812-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0812-2023 from Akorn. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
