Akorn recalls all Calcitriol Injection 2 mcg/mL ampules due to stability concerns after the manufacturer ceased operations. No remedy provided in official notice.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all Calcitriol Injection 2 mcg/mL, 1 mL ampules because the manufacturer went out of business and can no longer ensure product stability. This means the medication may not be safe for use after the recall date.
The manufacturer went out of business and stopped stability testing, meaning the medication's effectiveness and safety cannot be guaranteed. Without ongoing testing, there's a risk of the product degrading over time.
Patients prescribed Calcitriol Injection by healthcare providers. Those using the product without medical supervision are not affected.
Check for all Calcitriol Injection 2 mcg/mL, 1 mL ampules with any NDC number. The product was distributed by Akorn Operating Company, LLC in Gurnee, Illinois.
Identify the NDC number and lot number on the ampule to confirm it's part of the recall.
The recall states the manufacturer can no longer ensure stability, so the product may not be safe for use.
The official notice does not provide a specific remedy, so contact your healthcare provider for guidance.
Check the NDC number and lot number on the ampule; all products were recalled due to the manufacturer's closure.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0858-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0858-2023 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.
