Akorn recalls all 10mL Midazolam Injection vials due to stability study discontinuation after company closure. No remedy provided in official notice.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all 10mL Midazolam Injection vials because the manufacturer went out of business and could no longer conduct stability testing. This means the medication may not be safe for use as the quality cannot be verified.
The manufacturer went out of business and stopped stability testing, which is critical for ensuring the medication remains safe and effective over time. Without ongoing testing, the product's quality cannot be confirmed, potentially leading to unsafe use.
Prescribers and patients who have received this medication from a pharmacy or doctor. Those using the product without proper stability testing are at risk of potential safety issues.
All 10mL vials labeled 'Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intravenous Use Only' with the NDC code. The product was sold through pharmacies and doctors' offices.
Look for the product name and NDC code on the vial label to confirm it matches the recalled items.
The official recall notice does not provide any remedy or fix for this issue.
Check the vial label for 'Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intravenous Use Only' with the NDC code.
The recall notice does not specify a stop-use instruction, but the product's safety cannot be confirmed due to lack of stability testing.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0859-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0859-2023 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.
