Aurobindo Pharma USA Inc. recalls 400mg Rufinamide Tablets (120-count) due to cGMP deviations in batch production. This recall follows release of the batch before regulatory approval. No specific action steps are listed in the official notice.
cGMP deviations: Batch was released prior to approval.
Aurobindo Pharma is recalling 400mg Rufinamide Tablets in 120-count bottles that were manufactured in India and distributed in the U.S. The recall is due to quality control issues where the batch was released before receiving regulatory approval.
The batch of Rufinamide Tablets was released by the manufacturer before it received regulatory approval, which could mean the product does not meet safety standards. This cGMP (current Good Manufacturing Practice) deviation may lead to potential quality issues that could affect patient safety.
Prescription patients who have received the recalled 400mg Rufinamide Tablets in 120-count bottles. Patients using this medication for seizure disorders are most at risk due to the potential for quality issues.
Look for Rufinamide Tablets, USP 400 mg in 120-count bottles with the lot number RB4023002A and expiration date 02/2025. The product is distributed by Aurobindo Pharma USA Inc. in the U.S.
Verify the lot number and expiration date on the packaging to determine if the product is recalled.
The recall indicates potential quality issues, but the official notice does not specify if the product is safe to use. Patients should contact their healthcare provider for guidance.
The official recall notice does not provide specific action steps for affected patients. Consult your healthcare provider or the manufacturer for further instructions.
Check the lot number and expiration date on the packaging. The recalled product has lot number RB4023002A and expires 02/2025.
We’ve drafted a message you can send Aurobindo Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-1088-2023 — Aurobindo Pharma Aurobindo Pharma Hello, I own a Aurobindo Pharma that is covered by recall D-1088-2023 from Aurobindo Pharma. 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.
