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Recall Observatory FDA recall evidence

Drug product

Metoprolol Tartrate Tablets, USP, 100 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 69367-355-10

D-0582-2025

August 06, 2025

Class II

Product summary

Firm
Westminster Pharmaceuticals LLC
Event
Event 97395
Status
Ongoing
Classification
Class II
Quantity
4,456 1000-count bottles
Official record key
drug-enforcement:D-0582-2025

Official wording

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

Code information: Batch # R56240011, Exp Date: 2/28/26; Batch # R56240021, R56240031, Exp Date: 3/31/26; Batch # R56240041, R56240051, R56240061, Exp Date: 4/30/26; Batch # R56240071, Exp Date: 7/31/26

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations