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Recall Observatory FDA recall evidence

Drug product

Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05.

D-0451-2025

February 28, 2025

Class II

Product summary

Firm
Glenmark Pharmaceuticals Inc., USA
Event
Event 96861
Status
Ongoing
Classification
Class II
Quantity
18,696 bottles
Official record key
drug-enforcement:D-0451-2025

Official wording

Reason: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Code information: Lot, expiry: Lots 19231107, 19231114, 19231152, Exp Feb-25; Lot 19234866, Exp Jan-26

Distribution pattern: U.S. Nationwide

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations