Accord Healthcare is recalling 20 mg Atorvastatin Calcium Tablets USP (Rx only) manufactured in India with FDA inspection deviations. Products may contain unsafe levels of impurities.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling specific batches of 20 mg Atorvastatin Calcium Tablets USP (prescription-only) due to FDA inspection findings indicating potential impurities. This recall affects patients taking this medication as prescribed.
The FDA identified manufacturing deviations during an inspection that could result in impurities in the medication. These impurities may affect the safety and effectiveness of the drug when taken as prescribed.
Patients with a prescription for 20 mg Atorvastatin Calcium Tablets USP who received the recalled batches. Those with specific batch numbers and expiration dates listed in the recall notice are most at risk.
Check your prescription label for the product name 'Atorvastatin Calcium Tablets USP 20 mg', NDC codes 16729-045-15 or 16729-045-17, and batch numbers listed in the recall notice. The products were manufactured by Intas Pharmaceuticals in India.
Verify your prescription label for the product name, NDC codes, and batch numbers listed in the recall notice.
The FDA found manufacturing deviations during an inspection that could result in impurities in the medication.
No, but you should check if your medication is in the recalled batches and contact your doctor if you have concerns.
Check your prescription label for the product name 'Atorvastatin Calcium Tablets USP 20 mg', NDC codes 16729-045-15 or 16729-045-17, and 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-0372-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0372-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
