FDARecalled Aug 20, 2025 · #D-0582-2025
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: We...
Hazard
Class II — temporary health risk
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CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level. Classification: Class II Distribution: Nationwide in the USA.
Product details
- 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
- Type
- Drugs
- Manufacturer
- Westminster Pharmaceuticals LLC
- Model numbers
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- UPCs
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