Accord Healthcare recalls 40mg Pravastatin tablets after FDA inspection found manufacturing deviations. This recall affects specific batches produced in India with NDC 16729-010-17. No immediate action needed but check your bottle for batch numbers.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling 40mg Pravastatin Sodium Tablets in 1,000-count bottles due to FDA inspection finding manufacturing deviations. This recall affects specific batches produced in India with NDC 16729-010-17. The hazard is a regulatory issue that doesn't pose direct health risks to users but requires product removal from circulation.
The FDA identified manufacturing deviations during an inspection. This means the product was made under conditions that don't meet quality standards, but the recall is a regulatory action to ensure safety without direct health risks to users.
People with prescriptions for Pravastatin Sodium Tablets 40mg, 1,000-count bottles manufactured by Intas Pharmaceuticals in India. Those who have the specific batch numbers listed in the recall are most at risk.
Check your Pravastatin Sodium Tablets 40mg, 1,000-count bottle for the NDC code 16729-010-17 and batch number R2201294. The expiration date is August 31, 2025.
Look for the NDC code 16729-010-17 and batch number R2201294 on the bottle label.
No, the recall is due to FDA inspection findings, not a direct health hazard. The product is safe to use but must be removed from circulation.
Check for NDC code 16729-010-17 and batch number R2201294 on the bottle label.
The recall requires you to check your product details but no specific action is needed beyond verification.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0423-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0423-2023 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.
