Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey

Recall Number: D-0642-2024

Firm: FDC Limited

Classification: Class II

Status: Ongoing

Report Date: 20240828

Initiation Date: 20240812

Termination Date:

Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey