FDA recall D-0488-2024

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

Reason for recall

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

Distribution

New Jersey Only

Key facts

Status

Completed

Initiation date

2024-04-25

Report date

2024-05-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Aurangabad, Maharashtra State, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0488-2024