Accord Healthcare is recalling Glimepiride tablets (1 mg) from specific batches produced in India after FDA inspection found manufacturing deviations. These tablets may not meet quality standards.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling certain Glimepiride tablets (1 mg) that were manufactured in India and distributed in the U.S. due to FDA inspection finding quality control issues. This recall affects patients who may have taken these tablets and could pose risks from improper drug quality.
The FDA identified manufacturing deviations during an inspection, which could mean the tablets do not meet required quality standards. This might affect the drug's effectiveness or safety, though the exact risk is not specified in the recall notice.
Patients with diabetes who have been prescribed Glimepiride tablets (1 mg) from the recalled batches are affected. Those who have taken these specific batches may be at risk due to potential quality issues.
Check for Glimepiride tablets (1 mg) with NDC codes 16729-001-01 or 16729-001-16. The product was manufactured by Intas Pharmaceuticals in India and distributed in the U.S. from specific batch numbers listed in the recall.
Identify if your Glimepiride tablets (1 mg) have NDC codes 16729-001-01 or 16729-001-16 and the listed batch numbers.
The FDA found manufacturing deviations during an inspection, which could affect the quality of the tablets.
The recall notice does not specify a remedy, so contact your healthcare provider for guidance.
Yes, check for batch numbers like R2000166, P2003528, and others 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-0393-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0393-2023 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.
