The reason for 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 Enforcement Report of the United States Food and Drug Administration (USFDA) said.
Lupin Pharmaceuticals Inc is recalling 12,464 cartons of the Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and ethinyl estradiol tablets USP (0.01 mg) packaged in 1 extended-cycle wallet of 91 tablets packed in a pouch, it added.
The product was manufactured by Lupin Ltd at its Pithampur facility in Madhya Pradesh.
The voluntary ongoing nationwide recall is a class II recall, the report by the regulator said.
As per 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.