Timolol Maleate Ophthalmic Solution USP recall

Why it was recalled

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.

Details

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

Recalling company

Fdc Ltd

Classification

Class II

Status

Ongoing

Type

Voluntary: Firm initiated

Distribution

Nationwide U.S.A.

Initiated

Aug 12, 2024

FDA report date

Aug 28, 2024