FDA recall D-0632-2024

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; yellow colored spike from cap lodged in the nozzle

Distribution

Nationwide in the US

Key facts

Status
Ongoing
Initiation date
2024-07-18
Report date
2024-08-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Aurangabad, Maharashtra State, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0632-2024