FDA-Drug2025-08-20Class II
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
Westminster Pharmaceuticals LLC
Hazard
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Sold states
Nationwide in the USA.
Affected count
16,672 1000-count bottles
Manufactured in
1321 Murfreesboro Pike Ste 607, N/A, Nashville, TN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0581-2025Don't want to check this manually?
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