Lupin’s subsidiary -- Lupin Pharmaceuticals Inc is recalling over 12,000 cartons of Fayosim tablets, used to prevent pregnancy, from the American market. The reason for the recall is ‘Failed impurities/ degradation specifications: out-of-specification results observed in related substance test in Ethinyl Estradiol tablets USP 0.01mg at 12-month long-term stability study,’ according to the Enforcement Report of the United States Food and Drug Administration (USFDA).
The product was manufactured at the company’s Pithampur facility in Madhya Pradesh. The voluntary ongoing nationwide recall is a class-II recall. According to the 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 developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.
