Nationwide Recall of Glimepiride Tablets for Manufacturing Practice Deviations
Amerisource Health Services LLC recalls 63,335 bottles of Glimepiride Tablets nationwide due to manufacturing practice deviations identified during FDA inspection.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for manufacturing practice deviations without reported illnesses, injuries, or hospitalizations. The hazard is a manufacturing or quality control deficiency rather than a specific identified contaminant or defect.
Plain-English summary
Amerisource Health Services LLC is recalling 63,335 bottles of Glimepiride Tablets, USP, 1 mg nationwide. The recall includes both 100-count bottles (NDC# 68001-177-00) and 500-count bottles (NDC# 68001-177-03) manufactured by Intas Pharmaceuticals Limited in India.
The U.S. Food and Drug Administration identified deviations from Current Good Manufacturing Practice (CGMP) during an inspection. These manufacturing practice deviations prompted the recall of affected batches with various expiration dates identified by the FDA.
Consumers who have been prescribed this medication should speak with their healthcare provider or pharmacist about the recall for guidance on next steps.
The recalled product
- Product
- Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-177-03; Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug — Antidiabetic
- Hazard
- Affected units
- 63,335
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- Batches a) P2002616
- EXP 04/30/2023
- P2006509
- EXP 11/30/2023
- P2103572
- EXP 04/30/2024
- P2106811
- EXP 09/30/2024
- R2200578
- EXP 04/30/2025 b)P2100095
- P2100624
- EXP 01/31/2024
- P2101780
- EXP 02/29/2024
- P2107383
- P2201505
- EXP 02/28/2025
- R2201109
- EXP 06/30/2025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Amerisource Health Services LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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