Akorn recalls all Calcitriol Injection 1 mcg/mL 1mL 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 1 mcg/mL, 1 mL ampules because the manufacturer went out of business and can no longer verify product stability. This affects patients who need this medication for medical treatment.
The manufacturer went out of business and could no longer conduct stability studies to ensure the product remains safe and effective over time. Without these studies, there's uncertainty about whether the medication maintains its potency and safety.
Patients prescribed Calcitriol Injection by healthcare providers are affected. Those with medical conditions requiring this medication are at risk if they use unstable products.
Check for all Calcitriol Injection 1 mcg/mL, 1 mL ampules with any NDC number. The product was distributed by Akorn Operating Company, LLC in Gurnee, Illinois.
Identify the product by checking the NDC number and lot number on the ampule.
The official recall notice does not provide any remedy or fix for this issue.
All Calcitriol Injection 1 mcg/mL, 1 mL ampules with any NDC number are affected, as the manufacturer went out of business.
The recall notice does not specify a stop-use instruction, but patients should contact their healthcare provider for guidance.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0790-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0790-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
