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FDA (Drug enforcement)Recalled 2025-08-06class ii

Westminster Pharmaceuticals LLC: Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700

Hazard

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

Details from the source

Reason for recall: CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level. Distribution: Nationwide in the USA. Quantity: 4,456 1000-count bottles Lot/code info: 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

Source

Official record: FDA (Drug enforcement)

Republished from the official source above; details can change — the source record controls.

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