Akorn recalls Prometh: 6.25 mg/5mL oral solution bottles due to stability problems after company went out of business. All units affected.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all Promethazine HCl Oral Solution bottles because the company 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 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 not work as intended or could become unsafe.
People with prescriptions for Promethazine HCl Oral Solution from Akorn are affected. Those who have the product and need it for medical reasons are at risk.
Check for Promethazine HCl Oral Solution bottles labeled 6.25 mg/5mL, 473 mL, and Rx Only. All units are affected regardless of lot number or date.
Look for the product name, strength, and size on the bottle label.
Talk to your healthcare provider about alternative medications if you need this product.
The recall states the company can no longer ensure stability, so the product may not be safe. Consult your doctor for alternatives.
All Promethazine HCl Oral Solution bottles labeled 6.25 mg/5mL, 473 mL, and Rx Only are affected.
Contact your doctor to discuss alternatives, as the product may not be safe due to stability issues.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0838-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0838-2023 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.
