Sun Pharma, Dr Reddy's Labs and 2 others recall products in US
As per the USFDA, Sun Pharma is recalling 9,552 bottles of epilepsy treatment drug Divalproex Sodium delayed-release tablets due to "Failed Dissolution Specifications".
New Delhi: Leading generic drug makers Glenmark, Sun Pharma, Dr Reddy's and Jubilant Cadista are recalling multiple products in the US market, the world's largest market for medicines, for various issues. As per the latest Enforcement Report by the US Food and Drug Administration (USFDA), Mumbai-based drug firm Glenmark is recalling over 6.5 lakh tubes of a generic skin treatment ointment due to manufacturing issues.
New Jersey-based Glenmark Pharmaceuticals Inc, a subsidiary of the company, is recalling affected lot of Tacrolimus Ointment, which is used to treat eczema, due to "Defective Container", it added.
The company initiated the nationwide Class III recall on July 11 this year.
The affected lot has been manufactured in India and distributed in the US by Glenmark Pharmaceuticals Inc, the report stated.
As per the USFDA, 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."
As per the USFDA, Sun Pharma is recalling 9,552 bottles of epilepsy treatment drug Divalproex Sodium delayed-release tablets due to "Failed Dissolution Specifications".
The affected lot has been produced at the company's Halol plant in Gujarat and distributed in the US by Cranbury-based Sun Pharmaceutical Industries, Inc.
The drug initiated the Class II recall in the US on June 27 this year.
Similarly, the US-based arm of Dr Reddy's Laboratories is recalling 5,531 cartons of Lansoprazole delayed-release orally disintegrating tablets in two strengths due to failed dissolution specifications.
The New Jersey-based firm initiated the Class 11 nationwide recall on July 13.
Besides, Jubilant Cadista Pharmaceuticals is recalling 38,160 bottles of Irbesartan Tablets (150 and 75 mg), used to treat high blood pressure.
The affected lot has been produced at Jubilant Generics' Roorkee plant, USFDA said.
The Salisbury-based drug firm initiated the Class II recall on July 18.
As per the US health regulator, 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.
The US generic drug market was estimated to be around USD 115.2 billion in 2019. It is by far the largest market for pharmaceutical products in the world.
In the last financial year, India's pharma exports stood at around USD 24.62 billion with the US, the UK, South Africa, Russia, and Nigeria emerging as the top five destinations.
Read also: Glenmark, Sun Pharma recall products in US over manufacturing issues
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