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Lupin recalls over 12000 cartons of Fayosim from US market

Lupin recalls over 12000 cartons of Fayosim from US market

New Delhi: Drug firm Lupin is recalling over 12,000 cartons of Fayosim tablets, used to prevent pregnancy, from the American market, as per a report of the US 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 months 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.

Also Read: Lupin, YL Biologics gets PMDA approval for Etanercept biosimilar in Japan

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.”

Also Read : Lupin, Aurobindo Pharma recalls multiple lots of BP drug including VALSARTAN

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Farhat Nasim

Farhat Nasim

Farhat Nasim joined Medical Dialogue as Reporter in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier's College Ranchi. She can be contacted at Contact no. 011-43720751

Source: PTI
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