Akorn recalls all Lorazepam Oral Concentrate 2mg/mL 30mL bottles due to stability concerns after the manufacturer closed. No remedy provided in official notice.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all Loraz:epam Oral Concentrate 2mg/mL 30mL bottles because the manufacturer went out of business and can no longer ensure the product's stability. This means the medication may not be safe to use as intended.
The manufacturer went out of business and can 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 will maintain its intended properties.
Prescription patients who have received this specific lorazepam oral concentrate product from Akorn. Those with ongoing treatment needs are most at risk due to potential instability.
Check for 30mL bottles labeled 'Lorazepam Oral Concentrate, USP, 2mg per mL' with the Akorn brand. All products distributed by Akorn Operating Company, LLC in Gurnee, IL are affected.
Identify the product by checking the label for 'Lorazepam Oral Concentrate, USP, 2mg per mL' in 30mL bottles.
The manufacturer went out of business and can no longer continue stability studies to ensure the product remains safe and effective.
The official notice does not provide any remedy steps.
Check for 30mL bottles labeled 'Lorazepam Oral Concentrate, USP, 2mg per mL' with the Akorn brand.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0826-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0826-2023 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.
