Accord Healthcare recalls Atorvastatin Calcium 40mg tablets (NDC 16729-046-15 and 16729-046-17) following FDA inspection for CGMP deviations. Consumers should check batch numbers and expiration dates.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling Atorvastatin Calcium 40mg tablets due to manufacturing issues found during an FDA inspection. This recall affects specific batches that may contain unsafe levels of medication.
The FDA identified manufacturing deviations during an inspection, which could mean the tablets do not meet safety and quality standards. This may lead to inconsistent medication levels or potential safety risks for patients.
People who have the recalled Atorvastatin tablets with the listed NDC numbers and batch dates are affected. Those taking prescription statins for cholesterol management are most at risk.
Check the product label for NDC 16729-046-15 (90 tablets) or NDC 16729-046-17 (1,000 tablets). Look for batch numbers like R2100552, R2200253, or others listed with specific expiration dates.
Identify the NDC number and batch date on your Atorvastatin tablets to confirm if they are in the recalled list.
The FDA found manufacturing deviations during an inspection, which could affect the safety and quality of the medication.
Check the NDC number (16729-046-15 or 16729-046-17) and batch numbers like R2100552, R2200253, or others with specific expiration dates listed in the recall notice.
The recall does not specify a remedy, so contact your healthcare provider or pharmacist for guidance on next steps.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0373-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0373-2023 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.
