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Recall Observatory FDA recall evidence

Drug 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

D-0758-2023

March 17, 2023

Class II

Product summary

Firm
Amerisource Health Services LLC
Event
Event 92058
Status
Terminated
Classification
Class II
Quantity
105,361 bottles
Official record key
drug-enforcement:D-0758-2023

Official wording

Reason: CGMP Deviations: recalling drug products following an FDA inspection.

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

Distribution pattern: Nationwide USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations

Field note

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