FDA DrugClass IINotable
FDA Recall: Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesci
Description
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Hazard
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
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