Lupin recalls 16,056 bottles of tuberculosis drug Rifampin in US

The affected lot has been produced at Lupin's Aurangabad plant and marketed in the US by Baltimore-based Lupin Pharmaceuticals.

Published On 2023-01-21 09:19 GMT | Update On 2023-01-21 09:19 GMT

New Delhi: 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...

New Delhi: 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) recall of the affected lot on December 12 last year.

As per the 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.

The US generic drug market was estimated to be around USD 115.2 billion in 2019. It is the largest market for pharmaceutical products.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 8.7% of its revenue in research and development in FY22.

Article Source : with inputs

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Lupin recalls 16,056 bottles of tuberculosis drug Rifampin in US

The affected lot has been produced at Lupin's Aurangabad plant and marketed in the US by Baltimore-based Lupin Pharmaceuticals.

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