Zydus Pharmaceuticals (USA) Inc. is voluntarily recalling 36,624 bottles of Bromocriptine Mesylate Capsules (5 mg) because testing revealed levels of an impurity called 2-Bromoergine that exceed approved safety specifications. This medication is a prescription drug used to treat various conditions, including Parkinson's disease and certain hormone imbalances. If you use this medication, you should consult with your doctor or pharmacist to discuss your treatment options and how to return the affected product.
The recall is due to 'Out of Specification' results for the impurity 2-Bromoergine, which means the drug may contain degradation products at levels higher than what is deemed safe and effective by the FDA.
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Manufactured by Zydus Lifesciences Ltd., Ahmedabad, India.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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