The affected lot was manufactured at Lupin’s Aurangabad plant and distributed in the United States by Lupin Pharmaceuticals, based in Baltimore
Lupin is recalling 16,056 bottles of Rifampin Capsules, which are used to treat all forms of tuberculosis, from the US market due to a manufacturing issue. US health regulator’s report shows Lupin Pharmaceuticals recalling TB drug due to failed impurities/degradation specifications in the long-term stability study.
The affected lot was manufactured at Lupin’s Aurangabad plant and distributed in the US by Lupin Pharmaceuticals, based in Baltimore.
On December 12, last year, the company initiated a Class II nationwide (US) recall of the affected lot. A class II recall is initiated by the US Food and Drug Administration (US FDA) when the use or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.