FDA recall D-0403-2025

FDC Limited · Class II · drug

Product

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-01.

Reason for recall

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

Distribution

U.S. Nationwide

Key facts

Status
Ongoing
Initiation date
2025-04-18
Report date
2025-05-14
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-0403-2025