WhichRecall
Class IIReported 2025-01-15

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

Recalled by FDC Limited

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

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Recall Number
D-0182-2025
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2024-12-16
Reported
2025-01-15
Distribution
Nationwide
Code Info
Lot: 083L111, Exp. 11/30/2025; 084A032, Exp. 12/31/2025
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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