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

Recall Number: D-0182-2025

Firm: FDC Limited

Classification: Class II

Status: Ongoing

Report Date: 20250115

Initiation Date: 20241216

Termination Date:

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

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