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FDC Limited Recall: Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package

FDC Limited Recall: Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: FDC Limited; Product: Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma

Recalling firmFDC Limited
ProductCiprofloxacin 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 recallDefective 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
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusOngoing
DistributionNationwide
Recall initiated20241216
Recall numberD-0182-2025
Categorydrug
CountryIndia

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