Aurobindo Pharma, Unichem Laboratories Recall Products In US Market

Aurobindo Pharma and Unichem Laboratories are recalling different products in the US market, the world's largest market for medicines, due to manufacturing issues.

As per the latest enforcement report issued by the US Food and Drug Administration (USFDA), Aurobindo's US-based unit is recalling 7,296 containers of hypertension drug Carvedilol tablets.

The affected lot contains 6.25 mg Carvedilol tablets, which have been produced in India and distributed in the US by Princeton-based Aurobindo Pharma USA Inc.

The company is recalling the lot due to "failed impurities/degradation specifications", the US health regulator noted in the report. Aurobindo initiated the nationwide the recall on November 15 this year, it added.

Another domestic drug maker Unichem Laboratories is recalling 1,284 bottles of Topiramate tablets, used to treat epilepsy (seizures) and to prevent migraines. It is also used in the treatment of Lennox-Gastaut syndrome (a rare, but severe form of epilepsy that starts in early childhood).

The affected lot has been manufactured in Unichem's Ghaziabad-based plant and distributed in the US by New Jersey-based Unichem Pharmaceuticals (USA).

The US health regulator noted that the company is undertaking the voluntary recall of the affected lot due to "Discolouration". The company has initiated the recall process across the US on October 25.

The USFDA has classified both the recalls as class III.

As per the US health regulator, a class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences".

The US generic drug market was estimated to be around USD 115.2 billion in 2019. It is the largest market for pharmaceutical products.

Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.

We, however, have a request.

As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.

Support quality journalism and subscribe to Business Standard.

Digital Editor