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.
“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.
