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  • Manufacturing Defects:...

Manufacturing Defects: Glenmark Subsidiary Recalls Products in US

Written By : Meghna A Singhania Published On 2024-10-14T13:14:59+05:30  |  Updated On 17 Oct 2024 2:11 PM IST
Manufacturing Defects: Glenmark Subsidiary Recalls Products in US
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New York: Glenmark Pharmaceuticals is recalling two products in the U.S. due to manufacturing problems, as reported by the U.S. Food and Drug Administration. Glenmark Pharmaceuticals Inc, based in New Jersey and a subsidiary of Mumbai's Glenmark Pharmaceuticals, is recalling 45,504 bottles of Ryaltris Nasal Spray (containing olopatadine hydrochloride and mometasone furoate).
The company is recalling the affected lot due to "defective delivery system", the US Food and Drug Administration (USFDA) said in its latest enforcement report.
Read also: Glenmark Pharma recalls 114 batches of hypokalemia drug Potassium Chloride Extended Release in US
"The dip tube is clogged causing the spray not to work," it added.
Glenmark Pharmaceuticals Inc, USA, initiated the nationwide (US) Class II recall on September 24 this year.
As per 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.
The US health regulator said the drug firm is also recalling a generic medication to treat certain fungal skin infections.
Glenmark Pharmaceuticals Inc, US, is recalling 11,568 tubes of Ciclopirox Gel, produced at the company's Goa-based plant, due to "defective container"," USFDA stated.
Firm received complaints of broken tubes at the seal, it added.
The company initiated the Class III recall on September 30.
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".
India has the highest number of USFDA-compliant companies with plants outside the US.
The country is the largest supplier of generic medicines with around 20 per cent share in the global supply by manufacturing 60,000 different generic brands across 60 therapeutic categories.
The products manufactured in the country are shipped to over 200 countries around the globe, with Japan, Australia, West Europe, and the US as the main destinations.
Read also: Glenmark to commercialize BeiGene oncology medicines in India
Glenmark PharmaceuticalsUS Food and Drug AdministrationRyaltris Nasal Spraymanufacturing defects
Source : PTI
Meghna A Singhania
Meghna A Singhania

Meghna A Singhania is the founder and Editor-in-Chief at Medical Dialogues. An Economics graduate from Delhi University and a post graduate from London School of Economics and Political Science, her key research interest lies in health economics, and policy making in health and medical sector in the country. She is a member of the Association of Healthcare Journalists. She can be contacted at meghna@medicaldialogues.in. Contact no. 011-43720751

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