FDAFDA · Food and drugs·Recall number D-0759-2023
Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03, 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) P2003403, EXP 05/31/2023; P2006593, EXP 11/30/2023; P2101152, EXP 01/31/2024; P2105014, EXP 06/30/2024; R2101440, EXP 09/30/2024; P2200774, EXP 01/31/2025; R2200664, EXP 04/30/2025 b) P2100705, EXP 01/31/2024; P2104672, EXP 06/30/2024; R2101435, EXP 09/30/2024; R2200102, EXP 12/31/2024; R2200577, EXP 04/30/2025; P2205870, EXP 08/31/2025 [500 count] Lot, expiry: P2100121, exp 11/30/2023; P2100705, exp 01/31/2024; P2104672, exp 06/30/2024; R2101435, exp 09/30/2024; R2200102, exp 12/31/2024; R2200577, exp R2200577;P2205870, exp 08/31/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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