Accord Healthcare is recalling 10mg Rosuvastatin tablets (NDC 16729-285-15 and 16729-285-17) after FDA inspection found manufacturing deviations. Consumers should not use these products.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling 10mg Rosuvastatin tablets due to FDA inspection finding manufacturing deviations. This recall affects specific batches of the medication that were manufactured in India and distributed in the US. The hazard means the medication may not be safe for use as intended.
The FDA found manufacturing deviations during an inspection, which means the medication may not be produced to the required safety standards. This could potentially lead to the medication being ineffective or unsafe for patients.
People who have the specific 90-count or 1,000-count bottles of Rosuvastatin 10mg tablets with the listed NDC numbers are affected. Those taking this medication for cholesterol management are most at risk.
Check for the 90-count bottle (NDC 16729-285-15) or 1,000-count bottle (NDC 16729-285-17) with the listed batch numbers and expiration dates. The product is manufactured by Intas Pharmaceuticals in India.
Discard the recalled Rosuvastatin tablets immediately as they may not be safe for use.
The FDA found manufacturing deviations during an inspection, which means the medication may not be produced to the required safety standards.
The affected batches include specific production numbers like P2006824 (expiring 11/30/2023) and P2004949 (expiring 8/31/2023).
Check the product label for the NDC numbers 16729-285-15 (90-count bottle) or 16729-285-17 (1,000-count bottle).
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0405-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0405-2023 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.
