Akorn recalls acetaminophen and codeine phosphate oral solution due to CGMP deviations after the company went out of business. All products are affected.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling acetaminophen and codeine phosphate oral solution because the manufacturer went out of business and could no longer conduct stability tests. This means the product may not be safe for use.
The manufacturer went out of business and stopped stability testing, which means the product's safety and effectiveness could be compromised. Without ongoing testing, there's no guarantee the medication remains safe or works as intended.
People who have the 473mL bottles or 40 UD cups of this prescription medication are affected. Prescriptions for this product are at risk due to the manufacturer's closure.
Check for the product name 'Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL' in 473mL bottles or 40 UD cups. All lots and all NDCs are affected.
Look for the product name and packaging type (473mL bottles or 40 UD cups) to confirm if it's affected.
The manufacturer went out of business and could no longer continue stability studies, which means the product's safety and effectiveness could be compromised.
The recall applies to all products, but no specific deadline is mentioned in the official notice.
Check for the product name 'Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL' in 473mL bottles or 40 UD cups. All lots and all NDCs are affected.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0780-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0780-2023 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.
