Lupin recalls over 12,000 cartons of birth control tablets from US market

PTI New Delhi | Updated on April 07, 2019 Published on April 07, 2019

Drug firm Lupin is recalling over 12,000 cartons of Fayosim tablets, used to prevent pregnancy, from the American market, according to a report of the US health regulator.

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 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.

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.”

Published on April 07, 2019

A letter from the Editor

Dear Readers,

The coronavirus crisis has changed the world completely in the last few months. All of us have been locked into our homes, economic activity has come to a near standstill.

In these difficult times, we, at BusinessLine, are trying our best to ensure the newspaper reaches your hands every day. You can also access BusinessLine in the e-paper format – just as it appears in print. Our website and apps too, are updated every minute.

But all this comes at a heavy cost. As you are aware, the lockdowns have wiped out almost all our entire revenue stream. That we have managed so far is thanks to your support. I thank all our subscribers – print and digital – for your support.

I appeal to all our readers to help us navigate these challenging times and help sustain one of the truly independent and credible voices in the world of Indian journalism. You can help us by subscribing to our digital or e-paper editions. We offer several affordable subscription plans for our website, which includes Portfolio, our investment advisory section.

Our subscriptions start as low as Rs 199/- per month. A yearly package costs just Rs. 999 – a mere Rs 2.75 per day, less than a third the price of a cup of roadside chai..

A little help from you can make a huge difference to the cause of quality journalism!

Support Quality Journalism
This article is closed for comments.
Please Email the Editor