Akorn recalls all Guaifenesin Oral Solution (30:15mL, sugar-free, alcohol-free) for institutional use due to company closure preventing stability testing.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling all sugar-free, alcohol-free guaifenesin oral solution for institutional use because the manufacturer went out of business and can no longer test product stability. This means the product may not be safe for long-term use.
The manufacturer went out of business and can no longer perform stability studies. This means the product's safety and effectiveness over time cannot be confirmed, potentially leading to ineffective or unsafe medication.
Institutional users like hospitals and clinics that have this product. People using it for medical purposes under supervision are most at risk.
Check for the product name 'Guaifenesin Oral Solution', 300 mg/15 mL, sugar-free, alcohol-free, and labeled as 'For Institutional Use Only'. All lots and all NDCs are affected.
Verify the product name, strength, and labeling to confirm it matches the recalled item.
The recall states the manufacturer can no longer test stability, so safety cannot be confirmed. Do not use if you have the product.
Look for the product name 'Guaifenesin Oral Solution', 300 mg/15 mL, sugar-free, alcohol-free, and labeled as 'For Institutional Use Only'. All lots and NDCs are affected.
The recall does not specify a remedy, so contact the manufacturer for guidance. Do not use if you have the product.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0808-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0808-2023 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.
