Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ

Recall Number: D-0488-2024

Firm: FDC Limited

Classification: Class II

Status: Terminated

Report Date: 20240515

Initiation Date: 20240425

Termination Date: 20260521

Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.

Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ