Accord Healthcare recalls 80mg Pravastatin tablets from FDA inspection. Products may have manufacturing deviations. Consumers should check NDC 16729-011-15 and batch numbers for affected items.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling 80mg Pravastatin Sodium Tablets due to FDA inspection finding manufacturing deviations. This recall affects prescription-only bottles sold in the US with specific batch numbers and expiration dates.
The recall is triggered by FDA inspections identifying manufacturing deviations in the drug product. This means the tablets may not meet quality standards, though the specific risk to consumers is not detailed in the recall notice.
Prescription holders of the 80mg Pravastatin tablets with NDC 16729-011-15 and batch numbers R2201233. Individuals taking this medication should check if their bottle matches the recalled specifications.
Check for the NDC code 16729-011-15 and batch number R2201233 on the bottle. The product expires April 30, 2024, and was manufactured by Intas Pharmaceuticals in India.
Look for the NDC code 16729-011-15 and batch number R2201233 on the bottle label.
The FDA found manufacturing deviations during an inspection, which may affect the product's quality.
Check for NDC 16729-011-15 and batch number R2201233 on the bottle label. The product expires April 30, 2024.
The recall notice does not specify a remedy or action for consumers.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0424-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0424-2023 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.
