Zydus Pharmaceuticals (USA) Inc — Class II: Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zyd
Zydus Pharmaceuticals (USA) Inc. has initiated a Class II recall for Mirabegron Extended-Release Tablets (25 mg) due to an Out of Specification (OOS) result regarding N-Nitroso Mirabegron impurity levels. The recall is currently classified as ongoing and involves 30-count bottles manufactured in India.
This recall affects Zydus Pharmaceuticals (USA) Inc, Zydus Lifesciences Ltd., and pharmaceutical professionals involved in the distribution, quality oversight, and procurement of Mirabegron extended-release products.
The classification as a Class II recall indicates that the impurity levels, while not immediately life-threatening, could potentially cause temporary or medically reversible adverse health consequences. The citation of CGMP issues related to OOS results suggests potential gaps in impurity control or stability monitoring for this specific drug product. Regulatory and QA teams may see this as an indicator of continued FDA scrutiny regarding nitrosamine impurities in generic formulations.
Quality teams should review N-nitrosamine testing protocols for extended-release formulations and ensure that OOS investigation procedures for impurities are strictly followed to determine root causes and potential impact on other lots.
Class II. Reason: CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.. Product: Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1159-3.. Firm: Zydus Pharmaceuticals (USA) Inc (Pennington NJ United States). Status: Ongoing.
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