Azurity Pharmaceuticals recalls Eprontia (topiramate) oral solution due to impurity detected in stability testing. This medication is prescription-only and may pose risks if impurities are present.
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Azurity Pharmaceuticals is recalling a specific prescription topiramate oral solution product due to impurities found during stability testing. This could potentially affect medication safety if the impurities are present in the solution.
The recall is based on impurities detected during routine stability testing at 18 months. This impurity (4,5-desisopropylidene topiramate) could potentially affect the medication's safety and effectiveness if present in the solution.
Prescription patients using Eprontia (topiramate) oral solution from Azurity Pharmaceuticals. Those with the specific NDC 52652-9001-1 lot number MB22020B are most at risk.
Check for the product name Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL bottle, prescription-only. The specific lot number MB22020B (expiring 12/27/2023) is part of the recalled batch.
Identify the product by checking the NDC code 52652-9001-1 and lot number MB22020B on the label.
The recall indicates impurities were found during stability testing, but the official notice does not specify if the product is safe to use.
The official recall notice does not provide specific action steps for affected individuals.
Check the product label for NDC 52652-9001-1 and lot number MB22020B to confirm it is part of the recall.
We’ve drafted a message you can send Azurity to request your refund or repair — edit it as you like.
Subject: Recall D-0213-2024 — Azurity Azurity Hello, I own a Azurity that is covered by recall D-0213-2024 from Azurity. 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.
