Lupin’s arm recalling 16,056 bottles of Rifampin Capsules in US market

21 Jan 2023 Evaluate

Lupin's US-based subsidiary -- Lupin Pharmaceuticals Inc is recalling 16,056 bottles of Rifampin Capsules, a medication used in the treatment of all forms of tuberculosis, in the US market due to a manufacturing issue. The company 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. The drug initiated Class II nationwide (US) recall of the affected lot on December 12 last year.

As per US Food and Drug Administration (USFDA), a class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

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