Amerisource Health Services recalls Glimepiride 4mg tablets due to FDA inspection finding manufacturing deviations. Affected products include 100-count and 500-count bottles with specific NDC numbers and batch dates.
CGMP Deviations: recalling drug products following an FDA inspection.
Amerisource Health Services is recalling Glimepiride 4mg tablets after an FDA inspection found manufacturing deviations. This recall affects specific bottle sizes and batch numbers produced in India. Patients should check their product details to determine if they are affected.
The recall is due to manufacturing deviations found during an FDA inspection. This means the tablets may not meet quality standards, but the exact risk to patients is not specified in the recall notice.
Patients using Glimepiride 4mg tablets with the specific NDC numbers and batch dates listed in the recall are affected. Those with diabetes who take this medication are most at risk.
Check for the product name 'Glimepiride Tablets, USP, 4 mg, RX' and the NDC numbers 68001-179-00 (100-count) or 68001-179-03 (500-count). Also look for batch numbers and expiration dates listed in the recall.
Identify the NDC number and batch dates on your Glimepiride tablets to see if they match the recalled items.
The FDA found manufacturing deviations during an inspection, but the exact risk to patients is not specified in the recall notice.
Check your product details against the recalled NDC numbers and batch dates. If you have affected products, contact your healthcare provider.
The recall is due to manufacturing deviations, but the specific safety risks are not detailed in the official notice.
We’ve drafted a message you can send Amerisource Health Services to request your refund or repair — edit it as you like.
Subject: Recall D-0759-2023 — Amerisource Health Services Amerisource Health Services Hello, I own a Amerisource Health Services that is covered by recall D-0759-2023 from Amerisource Health Services. 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.
