Drug firm Lupin Ltd. is recalling over 12,000 cartons of Fayosim tablets, used to prevent pregnancy, from the American market, as per a report of the U.S. health regulator.
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 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.
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The product was manufactured by Lupin 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 U.S. FDA, 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."
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