Aurobindo Pharma USA Inc. recalls 200mg Rufinamide Tablets (120-count) due to cGMP deviations in batch production. This recall affects prescription-only medication distributed in the US. No specific action steps are listed in the official notice.
cGMP deviations: Batch was released prior to approval.
Aurobindo Pharma is recalling prescription 200mg Rufinamide tablets in 120-count bottles because the batch was released before regulatory approval. This means the medication may not meet safety standards and could pose risks if used without proper oversight.
The batch was released by the manufacturer before it received final regulatory approval. This could mean the medication does not meet required safety and quality standards, potentially leading to adverse effects if used without proper oversight.
Prescription patients who have received this specific batch of Rufinamide tablets. Those with seizure disorders requiring this medication are most at risk.
Check for the 120-count bottle labeled 'Rufinamide Tablets, USP 200 mg' with NDC 59651-616-08. The lot number RB2023001A was produced in India and expires February 2025.
Review the product label for NDC 59651-616-08 and lot number RB2023001A to confirm if it matches the recalled batch.
The recall indicates the batch was released before regulatory approval, so it may not meet safety standards. Consult your healthcare provider for guidance.
The official recall notice does not specify any action steps. Check the product label for the NDC and lot number to confirm if it's affected.
The recall notice does not mention any replacement or remedy options. Contact your healthcare provider for advice.
We’ve drafted a message you can send Aurobindo Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-1087-2023 — Aurobindo Pharma Aurobindo Pharma Hello, I own a Aurobindo Pharma that is covered by recall D-1087-2023 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.
