RecallDepth
Class II Ongoing

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

Company
Fdc Limited
Recall Initiated
December 16, 2024
Posted
January 15, 2025
Recall Number
D-0182-2025
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
136,181 bottles
Firm Location
Aurangabad, Maharashtra State, 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

Distribution

Nationwide

Lot / Code Info

Lot: 083L111, Exp. 11/30/2025; 084A032, Exp. 12/31/2025

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