New Delhi, Dec 5: 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. (PTI)
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