FDC Limited recalls Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aura…

Recall date

July 18, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0632-2024

FDA classification

Class II

Brand / firm

FDC Limited

Sold / distributed

Nationwide in the US

Why it was recalled

Defective container; yellow colored spike from cap lodged in the nozzle

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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].