Akorn recalls all Prometh: 6.25mg/10mg per 5mL oral solutions due to stability concerns after manufacturer went out of business.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling all Promethazine HCl and Codeine Phosphate oral solutions (6.25mg/1.0mg per 5mL) because the company went out of business and can no longer ensure product stability. This means the medication may not be safe to use as intended.
The manufacturer went out of business and stopped conducting stability studies. This means the product's safety and effectiveness could be compromised over time, potentially leading to reduced efficacy or unexpected reactions.
Prescription holders of this medication are affected. Patients using the product may face reduced effectiveness or safety issues due to stability concerns.
This product is labeled as Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, Rx Only. All National Drug Codes (NDCs) and all lots are affected.
Look for the product name and dosage on the label to confirm it matches the recalled items.
The manufacturer went out of business and can no longer continue stability studies, which means the product's safety and effectiveness could be compromised.
This product is labeled as Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, Rx Only. All National Drug Codes (NDCs) and all lots are affected.
The recall does not specify a remedy, so contact your healthcare provider for guidance on whether to continue using 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-0837-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0837-2023 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.
