Unichem Pharmaceuticals USA Inc. is recalling one lot of Bisoprolol Fumarate and Hydrochlorothiazide tablets (2.5 mg/6.25 mg), a prescription medication used to treat high blood pressure. The recall was initiated because the tablets do not meet the required specification limits for an impurity known as N-Nitroso Bisoprolol. This issue was discovered during testing for Current Good Manufacturing Practice (cGMP) deviations.
The product contains N-Nitroso Bisoprolol impurity levels that exceed established safety limits. Prolonged exposure to certain nitrosamine impurities may increase the risk of cancer over time.
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Recall #: D-0301-2026; Manufactured by Unichem Laboratories Ltd. in Goa, 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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