FDAFDA · Food and drugs·Recall number D-0757-2023
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
Published May 31, 2023 · Recall initiated: March 17, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: recalling drug products following an FDA inspection.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Amerisource Health Services LLC
- Distributor
- Nationwide USA
- Lot
- 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, EXP 11/30/2023; P2100624, EXP 01/31/2024; P2101780, EXP 02/29/2024; P2107383, EXP 09/30/2024; P2201505, EXP 02/28/2025; R2201109, EXP 06/30/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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