FDA-Drug2025-01-15Class II
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
FDC Limited
Hazard
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
Sold states
Nationwide
Affected count
136,181 bottles
Manufactured in
B-8 MIDC Industrial Area, Waluj District, Aurangabad, Maharashtra State, India
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0182-2025Don't want to check this manually?
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