FDC Limited recalls Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 69…

Recall date

July 23, 2024

Source

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

Recall number

D-0623-2024

FDA classification

Class II

Brand / firm

FDC Limited

Sold / distributed

U.S. A. Nationwide

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 bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 69315-308-02), Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India.