FDC Limited recalls Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma L…

Recall date

March 11, 2025

Source

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

Recall number

D-0282-2025

FDA classification

Class II

Brand / firm

FDC Limited

Sold / distributed

Nationwide in the U.S

Why it was recalled

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

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

What was recalled

Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05