Lupin recalls over 12,000 cartons of birth control tablets

Lupin 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.

The product was manufactured by Lupin Ltd. at its 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.