Recall D-0581-2025

US Class II Ongoing · initiated 2025-08-06

Recalling firm

Westminster Pharmaceuticals LLC, TN

Product

Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-354-10

Reason for recall

CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.

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