Recalls / Class II
Class IID-0758-2023
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
- Affected lot / code info
- 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
Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
Recalling firm
- Firm
- Amerisource Health Services LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 105,361 bottles
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2023-03-17
- FDA classified
- 2023-05-19
- Posted by FDA
- 2023-05-31
- Terminated
- 2024-09-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0758-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.