Drug recall D-0182-2025

Class II Ongoing reported Jan 15, 2025

Product

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

Lots and codes

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

Recall details

Recalling firm
FDC Limited, Aurangabad, Maharashtra State
Quantity
136,181 bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
December 16, 2024

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