Akorn recalls all Naloxone Injection 1mL vials due to inability to complete stability studies after going out of business. This affects all products with NDCs and lots.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all Nal:oxone injection vials because the company went out of business and can no longer complete stability testing. This means the product may not be safe for use as it could degrade over time.
The company went out of business and stopped stability testing, which means the product's safety and effectiveness over time cannot be confirmed. Without this testing, there's a risk the medication could degrade or become ineffective.
All owners of Naloxone injection vials, particularly those with prescriptions for opioid overdose treatment. People who use these products for medical emergencies are at risk if the product degrades.
Check for any Naloxone Injection 1mL vials with a prescription label. All products are affected regardless of lot or NDC number.
Look for Naloxone Injection 1mL vials with a prescription label.
The manufacturer went out of business and could no longer complete stability studies, so the product's safety and effectiveness over time cannot be confirmed.
No specific stop-use instruction is given; the recall is due to stability concerns, not immediate safety risks.
All Naloxone Injection 1mL vials with a prescription label are affected, regardless of lot or NDC number.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0830-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0830-2023 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.
