Accord Healthcare recalls specific batches of Clopidogrel 75mg tablets (Rx only) manufactured for FDA compliance issues. Affected products include 30-count, 90-count, and 500-count bottles with listed NDC and batch numbers. Consumers should check their product details and contact the manufacturer for guidance.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling certain batches of Clopidogrel 75mg tablets (Rx only) due to FDA inspection findings indicating manufacturing deviations. This recall affects specific product sizes and batch numbers, and consumers should verify their product details to determine if they are affected.
The recall is based on FDA inspections finding manufacturing deviations in the production process. This means the medication may not meet the required quality standards, potentially leading to ineffective treatment or other safety concerns. However, the exact nature of the deviations and their impact on patient safety are not specified in the recall notice.
Prescription medication users who have the specific batch numbers listed in the recall. Individuals with a prescription for Clopidogrel 75mg tablets and the affected product sizes (30-count, 90-count, or 500-count bottles) are most at risk.
Check your Clopidogrel 75mg tablets (Rx only) for the following product sizes: 30-count, 90-count, or 500-count bottles. Look for the NDC numbers 16729-218-10, 16729-218-15, or 16729-218-16, and the corresponding batch numbers listed in the recall.
Verify your Clopidogrel 75mg tablets (Rx only) to see if they match the product sizes and batch numbers listed in the recall.
The recall is due to FDA inspections finding manufacturing deviations in the production process, which may affect the medication's quality and safety.
Check your product details to see if you have the affected batches. If you do, contact Accord Healthcare for further instructions.
The recall notice does not specify the exact risks, only that there were manufacturing deviations found during FDA inspections.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0380-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0380-2023 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.