As per a report of the U.S health regulator, drug firm Lupin Ltd. is recalling over 12,000 cartons of Fayosim Tablets which is birth control tablets, used to prevent pregnancy, from the American Market.
12,464 cartons of 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 in addition; is been recalled by Lupin Pharmaceuticals Inc.
“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 said stating the reasons for recalling.
“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,” a class-II recall has been initiated as per the U.S FDA.
The products were manufactured by Lupin at its Pithampur Facility in Madhya Pradesh.
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