Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distribute...
FDA Recall #D-0282-2025 — Class II — March 11, 2025
Product Description
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
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, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
90960 bottles
Distribution
Nationwide in the U.S
Code Information
Lot: 084A067, Exp 12/31/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated