Akorn recalls all Granisetron HCl injection vials due to stability concerns after the company ceased operations. No remedy specified in official notice.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all Granisetron HCl injection vials (1mL and 4mL) because the manufacturer went out of business and can no longer conduct stability testing. This means the product's safety cannot be guaranteed.
The manufacturer went out of business and stopped all stability testing. Without ongoing testing, the medication's effectiveness and safety cannot be confirmed over time.
All healthcare providers and patients prescribed this medication by a doctor. Those using the product without medical supervision are at risk.
Look for Granisetron HCl injection vials labeled 1mL or 4mL, manufactured by Akorn, Inc. All lots and all National Drug Codes (NDCs) are affected.
Identify the product by checking the vial size (1mL or 4mL) and manufacturer label.
The manufacturer went out of business and could no longer continue stability studies, so the product's safety cannot be guaranteed.
The official notice does not specify any remedy.
Look for Granisetron HCl injection vials (1mL or 4mL) with the manufacturer label 'Akorn, Inc.' and all National Drug Codes (NDCs).
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0806-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0806-2023 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.
