Akorn recalls all Lactulose Solution 30mL unit dose cups due to inability to complete stability studies after going out of business. This affects all units sold.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all Lact:ulose Solution 30mL unit dose cups because the company went out of business and could no longer run stability tests. This means the product may not be safe for long-term use.
The manufacturer went out of business and stopped stability testing. This means the product's safety over time isn't confirmed, but it doesn't pose an immediate danger.
Prescription patients using Lactulose Solution 30mL unit dose cups. Those with the product are most at risk if they need long-term use.
Check for Lactulose Solution 30mL unit dose cups with any NDC number. All lots and all units are affected.
Look for the product name and NDC number on the cup to confirm it's affected.
The manufacturer went out of business and could no longer complete stability studies, so the product's long-term safety isn't confirmed.
No immediate action is needed, but you should check if you have the product and consider alternatives if you need long-term use.
The official recall doesn't provide a fix; the product is affected but no remedy is stated.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0815-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0815-2023 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.
