Aurobindo Pharma USA Inc is recalling one lot of Nebivolol (2.5 mg) tablets, a medication used to treat high blood pressure, because it contains an impurity known as N-Nitroso Nebivolol. Testing revealed that this impurity level exceeds the acceptable daily intake limit set by regulatory standards. Consumers should consult with their healthcare provider or pharmacist about their treatment before stopping the medication.
The tablets contain a nitrosamine impurity, which is classified as a probable human carcinogen. Long-term exposure to this substance above acceptable limits may increase the risk of developing cancer.
You have 2 options:
Rx only; distributed by Aurobindo Pharma USA, Inc.
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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