FDA recall D-0642-2024

Product

Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey

Reason for recall

Defective Container: patients are 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

Nationwide U.S.A.

Key facts

Status

Ongoing

Initiation date

2024-08-12

Report date

2024-08-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Aurangabad, Maharashtra State, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0642-2024