Glenmark arm recalls two products in the US due to production issues

Representative image: The company initiated the Class III recall on September 30. (Photo: Shutterstock)

2 minutes reading Last updated: October 13, 2024 | 12:16 pm IST

Drug manufacturer Glenmark is recalling two products in the US due to production problems, according to the US Food and Drug Administration.

New Jersey-based Glenmark Pharmaceuticals Inc, USA, a unit of Mumbai-based Glenmark Pharmaceuticals, is recalling 45,504 bottles of Ryaltris (olopatadine hydrochloride and mometasone fluorate) nasal spray.

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The company is recalling the affected batch due to a “defective delivery system,” the U.S. Food and Drug Administration (USFDA) said in its latest enforcement report.

“The dip tube is clogged causing the spray to not work,” he added.

Glenmark Pharmaceuticals Inc, USA, initiated the nationwide (US) Class II recall on September 24 this year.

According to the USFDA, a Class II recall is initiated in a situation where use of or exposure to an violative product may cause temporary or medically reversible adverse health effects or where the likelihood of serious adverse health effects is remote.

The US health regulator said the pharmaceutical company is also recalling a generic drug used to treat certain fungal infections of the skin.

Glenmark Pharmaceuticals Inc, US, is recalling 11,568 tubes of Ciclopirox Gel manufactured at the company’s facility in Goa due to “defective container”, the USFDA said.

The company received complaints about broken pipes at the seal, it added.

The company initiated the Class III recall on September 30.

According to the USFDA, a Class III recall is initiated in a “situation where use of or exposure to an violative product is not likely to cause adverse health effects.”

India has the largest number of USFDA compliant companies with factories outside the US.

The country is the largest supplier of generic medicines with an approximately 20 percent share of the global supply through the production of 60,000 different generic brands in 60 therapeutic categories.

The products manufactured in the country are shipped to more than 200 countries around the world, with Japan, Australia, Western Europe and the US as the major destinations.

(Only the headline and image of this report may have been reworked by Business Standard staff; the rest of the content is automatically generated from a syndicated feed.)

First publication: October 13, 2024 | 12:16 pm IST

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