Glimepiride Tablets recalled due to manufacturing practice deviations
Amerisource Health Services is recalling 105,361 bottles of Glimepiride Tablets nationwide following FDA discovery of manufacturing practice deviations. No illnesses have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall following discovery of Current Good Manufacturing Practice deviations. No illnesses or injuries have been reported, but CGMP violations represent potential risks to drug quality and safety.
Plain-English summary
Amerisource Health Services LLC is recalling 105,361 bottles of Glimepiride Tablets, USP, 2 mg, a prescription medication distributed nationwide. The recall was initiated following FDA discovery of Current Good Manufacturing Practice (CGMP) deviations at the manufacturing facility.
The affected medication was manufactured by Intas Pharmaceuticals Limited in Ahmedabad, India. The recall includes multiple batches with expiration dates ranging from May 2023 through July 2025.
Consumers with prescriptions for this medication should contact their healthcare provider or pharmacist to determine if their supply contains affected batches. Patients should not discontinue their medication without consulting their doctor. No illnesses or injuries related to this recall have been reported.
The recalled product
- Product
- Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 68001-178-03 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. For BluePoint Laboratories
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug
- Hazard
- cgmp-deviation
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)P2003493
- EXP 05/31/2023
- P2100120
- EXP 11/30/2023
- P2100683
- EXP 01/31/2024
- P2106002
- EXP 07/31/2024
- R2200148
- EXP 12/31/2024
- R2201125
- EXP 06/30/2025 b) P2003403
- b) P2005800
- EXP 09/30/2023
- P2101156
- P2105401
- R2200083
- R2201004
- EXP 07/31/2025
Distribution
Distributed nationwide across the United States.
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