Drug Enforcement D-0450-2025

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

Status

Ongoing

Classification

Class II

Report Date

June 4, 2025

Termination Date

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Product Information

Product description
Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-164-05
Product quantity
84,048 bottles
Reason for recall
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
U.S. Nationwide

Location & Firm

Recalling firm
Glenmark Pharmaceuticals Inc., USA
Address
750 Corporate Dr, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0450-2025
Event ID
96861
Recall initiation date
February 28, 2025
Center classification date
May 28, 2025
Code info
Lot, Exp: Lots 19231899, 19231922, 19231927, 19231967, 19231979, Exp Apr-25; Lots 19232226, 19232234, 19232265, 1923227,1 Exp May-25; Lots 19232758, 19232759, 19232762, 19232788, Exp Jun-25
More code info
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