Glenmark Recalls Two Products in the US Due to Manufacturing Issues

Glenmark Pharmaceuticals is recalling two products in the United States due to manufacturing issues, according to the latest report from the US Food and Drug Administration (USFDA). Glenmark Pharmaceuticals Inc., USA, the New Jersey-based subsidiary of Mumbai’s Glenmark Pharmaceuticals, has initiated recalls for Ryaltris Nasal Spray and Ciclopirox Gel.

The company is recalling 45,504 bottles of Ryaltris (olopatadine hydrochloride and mometasone furoate) Nasal Spray due to a defective delivery system. The USFDA report states that a clogged dip tube prevents the spray from functioning properly. This Class II recall was initiated on September 24, 2024. A Class II recall refers to situations where exposure to a product may lead to temporary or medically reversible adverse health consequences, though the probability of serious harm is remote.

In addition, Glenmark Pharmaceuticals Inc. is also recalling 11,568 tubes of Ciclopirox Gel, a generic antifungal medication, due to defective containers. The USFDA cited customer complaints about broken tubes at the seal. This led the company to initiate a Class III recall on September 30, 2024. Class III recalls involve situations where the use of a product is not likely to cause adverse health effects.

India, a major supplier of generic medicines globally, has the highest number of USFDA-compliant manufacturing plants outside the United States. Glenmark’s recalls highlight the stringent regulatory standards pharmaceutical companies must meet to ensure product safety and efficacy. Indian pharmaceutical products, including generics, are shipped to over 200 countries, with key markets in the US, Japan, Australia, and Western Europe.
Glenmark Pharmaceuticals is a global pharmaceutical company headquartered in Mumbai, India, with a strong presence in generic drug manufacturing and research in various therapeutic categories. The company operates in more than 80 countries and is dedicated to developing affordable, high-quality medicines to meet global healthcare needs.

(Inputs are taken from PTI)