Westminster Pharmaceuticals recalls 16,672 boxes of Metoprolol Tartrate 50 mg tablets nationwide after nitrosamine exceeds Acceptable Daily Intake. Manufactured by Renata PLC in Bangladesh and distributed in the US by Westminster Pharmaceuticals. Consumers should stop using the product and contact their healthcare provider for guidance.
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Consumers and healthcare providers should stop using this product immediately. Contact Westminster Pharmaceuticals LLC or your healthcare provider for guidance. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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Metoprolol tartrate is a beta-blocker used to treat high blood pressure and other heart-related conditions. It is prescribed and distributed as a generic medication.
Nitrosamines are potential carcinogens. Exceeding ADI implies potential long-term cancer risk with prolonged exposure.
This recall is part of ongoing FDA monitoring for nitrosamine contaminants in human drugs.
The recall affects patients relying on these tablets for cardiovascular conditions. It requires immediate termination of use and medical consultation for alternatives.
NDC 69367-354-10 on label; batch number on bottle label.
Refunds or replacements typically take 4-8 weeks after verification.
Keep all recall notices, bottle labels, batch numbers, and communications with pharmacy or provider. Save receipts and timelines.
Metoprolol Tartrate Tablets, USP, 50 mg, 1000-count bottles. 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. Batch numbers include R55230021 through R55230151 and R55240011, R55240021. Quantity recalled: 16,672 bottles. Sold nationwide in the USA.
No injuries or incidents have been reported in the provided data.
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