Drug Enforcement D-0451-2025

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 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.
Product quantity
18,696 bottles
Reason for recall
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Recall initiation reason
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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
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Codes & Dates

Recall number
D-0451-2025
Event ID
96861
Recall initiation date
February 28, 2025
Center classification date
May 28, 2025
Code info
Lot, expiry: Lots 19231107, 19231114, 19231152, Exp Feb-25; Lot 19234866, Exp Jan-26
More code info
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