Accord Healthcare recalls Vigabatrin oral solution (500mg) due to FDA inspection finding manufacturing deviations. Affected products include specific NDC and batch numbers. Consumers should contact the manufacturer for details.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare has recalled Vigabatrin oral solution (500mg) because an FDA inspection found manufacturing deviations. This recall affects specific batches and packaging with unique identifiers. The product is prescription-only and should be checked for the listed NDC and batch numbers.
The FDA identified manufacturing deviations during an inspection. This means the product may not meet quality standards, but the recall does not specify the exact risk to health or safety.
Prescription patients using Vigabatrin oral solution (500mg) with the specific NDC and batch numbers listed. Those who have the product from the recall batch are most at risk.
Check the product's NDC code (16729-521-63 for packets, 16729-521-11 for cartons) and batch number (R2100308) on the packaging. The product was manufactured for specific locations in the US and India.
Look for the NDC code 16729-521-63 on the packet and 16729-521-11 on the carton, along with batch number R2100308.
The FDA found manufacturing deviations during an inspection, so the product was recalled to ensure quality standards.
Check the NDC code on the packet (16729-521-63) and carton (16729-521-11), and batch number R2100308.
The recall does not specify a remedy, so contact Accord Healthcare for further instructions.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0418-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0418-2023 from Accord Healthcare. 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.
