Glenmark Pharmaceuticals has announced the recall of two products in the United States, citing manufacturing issues that could affect their effectiveness and safety. The U.S. Food and Drug Administration (USFDA) reported that the recalls involve significant quantities of two medications.
The first recall affects 45,504 bottles of Ryaltris (olopatadine hydrochloride and mometasone furoate) Nasal Spray. Glenmark Pharmaceuticals Inc., based in New Jersey and a subsidiary of the Mumbai-based Glenmark Pharmaceuticals, initiated a nationwide Class II recall on September 24. The recall was prompted by a “defective delivery system,” with reports indicating that the dip tube is clogged, rendering the spray ineffective.
In addition, the company is recalling 11,568 tubes of Ciclopirox Gel, a generic medication for fungal skin infections. This Class III recall, initiated on September 30, was due to complaints of broken tubes at the seal, as stated by the USFDA. A Class III recall indicates that the product is unlikely to cause adverse health consequences.
The US FDA classifies recalls based on the level of risk associated with the product, with Class II recalls suggesting the potential for temporary or medically reversible health effects, and Class III recalls indicating a low likelihood of serious health risks.
Glenmark’s manufacturing facility in Goa produced the Ciclopirox Gel, which underscores the company’s broad impact in the U.S. market. India boasts the highest number of USFDA-compliant pharmaceutical companies operating outside the U.S., contributing significantly to global medicine supply, particularly in the generic sector.
Glenmark’s recalls serve as a reminder of the rigorous standards required in pharmaceutical manufacturing, ensuring patient safety and product reliability.
