Riboflavin 5-Phosphate Ophthalmic

FDC Limited has initiated a Class II recall of 155,232 bottles of Timolol Maleate Ophthalmic Solution USP, 0.5%, due to defective containers. This marks the third such recall for the Aurangabad, India-based manufacturer in 2024, distributed by Rising Pharma Holdings, Inc. This recurring issue underscores significant quality control deficiencies, posing substantial supply chain and regulatory risks for procurement and regulatory affairs teams.

FDC Limited initiated a Class II recall of 382,104 units of Timolol Maleate Ophthalmic Solution due to a defective container, impacting distributor Rising Pharma Holdings, Inc. This event from the Aurangabad, India facility underscores critical quality control needs for sterile products, demanding enhanced vigilance from procurement and regulatory teams.