Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-...
FDA Recall #D-0623-2024 — Class II — July 23, 2024
Product Description
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.
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
66,528 bottles
Distribution
U.S. A. Nationwide
Code Information
Lot#: a) 084C040, Exp 02/28/2026; b) 084A024, Exp12/31/2025.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated