RecallWatchUSA

Home / Recalls / Drugs

FDC Limited recalls Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC

Recalled May 15, 2024 · FDA recall D-0488-2024 · FDC

Hazard
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers. · FDA Class II
Units
382,104 units
Sold at
New Jersey Only

Description

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

Product
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
Manufacturer(s)
FDC Limited
Made in
India

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

FDC Limited recalls Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC | RecallWatchUSA