Amerisource Health Services recalls Glimepiride 2mg tablets due to FDA inspection findings. Products with NDC numbers 68001-178-00 and 68001-178-03 may be affected.
CGMP Deviations: recalling drug products following an FDA inspection.
Amerisource Health Services is recalling Glimepiride 2mg tablets from specific bottle counts and NDC numbers after an FDA inspection found manufacturing deviations. This recall addresses potential quality issues that could affect drug safety.
The recall is triggered by FDA inspections identifying manufacturing deviations in the production process. These deviations could potentially impact the quality and safety of the medication, though the specific risks are not detailed in the notice.
People who have the recalled Glimepiride tablets (2mg, 100-count or 500-count bottles) with the specified NDC numbers. Those using these medications for diabetes management are most at risk.
Check for Glimepiride Tablets, 2mg, 100-count bottles (NDC# 68001-178-00) or 500-count bottles (NDC# 68001-178-03). The products were manufactured by Intas Pharmaceuticals Limited in India.
Identify if your Glimepiride tablets are in the recalled batches with NDC numbers 68001-178-00 or 68001-178-03.
The FDA found manufacturing deviations during an inspection, which could affect the quality and safety of the medication.
The recall notice does not specify a remedy, so contact Amerisource Health Services for further instructions.
The affected batches include P2003493, P2100120, P2100683, P2106002, R2200148, R2201125 for 100-count bottles and P2003403, P2005800, P2101156, P2105401, R2200083, R2201004 for 500-count bottles.
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-0758-2023 — Amerisource Health Services Amerisource Health Services Hello, I own a Amerisource Health Services that is covered by recall D-0758-2023 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.
