Glenmark Pharmaceuticals’ US-based subsidiary -- Glenmark Pharmaceuticals Inc, is recalling 45,504 bottles of Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, due to ‘defective delivery system’. Glenmark Pharmaceuticals Inc, USA, initiated the nationwide (US) Class II recall on September 24, 2024. As per the US Food and Drug Administration (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.
Additionally, Glenmark Pharmaceuticals Inc, is also recalling 11,568 tubes of Ciclopirox Gel, produced at the company's Goa-based plant, due to defective container. Glenmark Pharmaceuticals Inc initiated the Class III recall on September 30, 2024. 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.
Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.