D-0758-2023 Class II Terminated
FDA drug recall D-0758-2023 was initiated by Amerisource Health Services LLC on March 17, 2023 and is designated Class II. Reason for recall: CGMP Deviations: recalling drug products following an FDA inspection. The recall status is terminated (terminated September 6, 2024). Affected quantity: 105,361 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 31, 2023
- Initiation Date
- March 17, 2023
- Termination Date
- September 6, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 105,361 bottles
Product Description
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
Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Distribution Pattern
Nationwide USA
Code Information
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, EXP 05/31/2023; b) P2005800, EXP 09/30/2023; P2101156, EXP 01/31/2024; P2105401, EXP 07/31/2024; R2200083, EXP 12/31/2024; R2201004, EXP 07/31/2025