Lupin recalls over 16,000 bottles of generic tuberculosis drug in US ...Middle East

Business Standard - Economy
source : Business Standard ( Middle East ) () 39
Drug maker Lupin is recalling 16,056 bottles of Rifampin Capsules, used in the treatment of all forms of tuberculosis, in the US market due to a manufacturing issue, according to the US Food and Drug Administration. As per the latest Enforcement Report by the US health regulator, Lupin Pharmaceuticals Inc, a US-based arm of the Mumbai-based drug major, is recalling the affected lot due to "Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study." The affected lot has been produced at Lupin's Aurangabad plant and marketed in the US by Baltimore-based Lupin Pharmaceuticals. The company initiated Class II nationwide (US) recal

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