FDA-Drug2024-08-07Class II
Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 69315-308-02), Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India.
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
U.S. A. Nationwide
Affected count
66,528 bottles
Manufactured in
B-8 MIDC Industrial Area, Waluj District, Aurangabad, Maharashtra State, N/A, India
Products
Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 69315-308-02), Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0623-2024Don't want to check this manually?
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