Akorn recalls all 237mL Cimetidine HCl Oral Solution bottles due to stability problems after the manufacturer went out of business.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling all 237mL bottles of Cimetidine HCl Oral Solution (Rx only) because the manufacturer 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 manufacturer went out of business and stopped stability testing, which means the medication's effectiveness and safety could be compromised over time. This is a quality issue rather than an immediate safety hazard.
Prescription patients who have received this medication from a pharmacy. Those who have the product are most at risk if they use it without checking stability.
Check for 237mL bottles labeled 'Cimetidine HCl Oral Solution 300mg/5mL' with Rx only status. All lots and all National Drug Codes (NDCs) are affected.
Verify if you have the recalled 237mL Cimetidine HCl Oral Solution bottles with Rx only status.
The recall states the manufacturer can no longer ensure stability, so it may not be safe to use as intended.
Look for 237mL bottles labeled 'Cimetidine HCl Oral Solution 300mg/5mL' with Rx only status; all lots and NDCs are affected.
The recall does not specify a remedy, so check with your pharmacist or healthcare provider for guidance.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0793-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0793-2023 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.
