Accord Healthcare is recalling specific batches of Atorvastatin Calcium 80mg tablets after FDA inspection found manufacturing deviations. Consumers should check their product labels for NDC codes and batch numbers to determine if affected.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling certain batches of Atorvastatin Calcium 80mg tablets due to FDA inspection finding manufacturing deviations. This recall affects prescription-only medication that may be unsafe if used as intended.
The FDA identified manufacturing deviations during an inspection of the drug production process. This means the tablets may not meet quality standards and could be unsafe for use, though the exact risk is not specified in the recall notice.
Prescription holders of the recalled Atorvastatin Calcium 80mg tablets. Patients taking this medication should check if their specific batch number is listed in the recall.
Check the product label for NDC code 16729-047-15 (90 tablets) or 16729-047-16 (500 tablets). Look for batch numbers R2100283, R2100288, R2100289, R2200235, R2200952, R2201037, R2100291, R2100281, R2100282, R2100292, R2100293, R2100294, R2100290, R2100306, R2100348, R2100349, R2100347, R2100350, R2100356, R2100355, R2100461, R2100463, R2100464, R2101214, R2101215, R2101216, R2101572, R2101573, R2101577, R2101578, R2101585, R2101579, R2101584, R2101587, R2101597, or R2200801.
Look for NDC codes 16729-047-15 (90 tablets) or 16729-047-16 (500 tablets) on the packaging.
Confirm if your batch number matches any listed in the recall notice (e.g., R2100283, R2200235, etc.).
The FDA identified manufacturing deviations during an inspection of the drug production process, which may affect the safety of the tablets.
Check the product label for NDC codes 16729-047-15 or 16729-047-16 and batch numbers listed in the recall notice.
The recall notice does not specify a remedy, so contact your healthcare provider for guidance on whether to stop using the medication.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0374-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0374-2023 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.
