FDAClass IIJanuary 15, 2025

Ciprofloxacin Ophthalmic Solution USP recall

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

Why was Ciprofloxacin Ophthalmic Solution USP recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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
Recalling firm
FDC Limited
Quantity
136,181 bottles
Distribution
Nationwide
Recall date
January 15, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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