Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, D...
FDA Recall #D-0182-2025 — Class II — December 16, 2024
Product Description
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
Reason for Recall
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
Recalling Firm
FDC Limited — Aurangabad, Maharashtra State
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
136,181 bottles
Distribution
Nationwide
Code Information
Lot: 083L111, Exp. 11/30/2025; 084A032, Exp. 12/31/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated