Akorn recalls all 50mg/5mL oral solution bottles due to stability concerns after company went out of business. No remedy provided in official notice.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling all bottles of Amant: 50mg/5mL oral solution because the company closed and can't do stability testing anymore. This means the product might not be safe to use as intended.
The company went out of business and stopped stability testing, which means the product's safety and effectiveness could be compromised over time. Without ongoing testing, the medication might degrade or become unsafe.
Prescription patients who have the Amantadine Hydrochloride Oral Solution bottles. Those with the product are at risk if they use it without proper stability testing.
Check for bottles labeled 'Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL' with prescription status. All lots and all NDC numbers are affected.
Identify if you have the recalled Amantadine Hydrochloride Oral Solution bottles with prescription status.
The company went out of business and can no longer perform stability testing, which could affect the product's safety and effectiveness.
The official notice does not provide a specific remedy or action for the product.
The recall is due to stability concerns after the company closed, but the official notice does not specify injury risks.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0857-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0857-2023 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.
