Accord Healthcare is recalling 10mg Atorvastatin Calcium Tablets USP (NDC 16729-044-15 and 16729-044-17) 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 specific batches of 10mg Atorvastatin Calcium Tablets USP due to manufacturing deviations found during an FDA inspection. This recall affects prescription-only medication that could pose risks if used as intended.
The recall is triggered by FDA inspections identifying manufacturing deviations in the production process. These deviations could affect the safety and quality of the medication, potentially leading to improper dosing or ineffective treatment.
Prescription holders of the recalled 10mg Atorvastatin Calcium Tablets USP (NDC 16729-044-15 and 16729-044-17) who have the specified batch numbers. Patients with high cholesterol or other conditions requiring statins are most at risk.
Check the product label for the NDC code 16729-044-15 (90 tablets) or 16729-044-17 (1,000 tablets). Look for batch numbers R2100455 through R2200945 with specific expiration dates listed in the recall notice.
Immediately stop using the recalled Atorvastatin Calcium Tablets USP if you have the specified batch numbers.
The FDA identified manufacturing deviations during an inspection, which could affect the safety and quality of the medication.
Affected batches include R2100455 through R2200945 with specific expiration dates as listed in the recall notice.
Check the product label for NDC codes 16729-044-15 or 16729-044-17 and the batch numbers listed in the recall notice.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0371-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0371-2023 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.
