D-0757-2023 Class II Terminated
FDA drug recall D-0757-2023 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: 63,335 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
- 63,335 bottles
Product Description
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
Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Distribution Pattern
Nationwide USA
Code Information
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