Ciprofloxacin ophthalmic solution USP recall

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.

Details

Product

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.

Recalling company

Fdc Ltd

Classification

Class II

Status

Ongoing

Type

Voluntary: Firm initiated

Distribution

U.S. A. Nationwide

Initiated

Jul 23, 2024

FDA report date

Aug 7, 2024