FDA recall D-0543-2025

FDC Limited · Class II · drug

Product

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.

Reason for recall

Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.

Distribution

U.S Nationwide.

Key facts

Status
Ongoing
Initiation date
2025-07-05
Report date
2025-08-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Aurangabad, Maharashtra State, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0543-2025