FDC Limited

FDA Regulatory Profile

Summary

Total Recalls
11
510(k) Clearances
0
Inspections
12
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0543-2025Class IITimolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC LJuly 5, 2025
D-0403-2025Class IITimolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC April 18, 2025
D-0282-2025Class IICiprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed bMarch 11, 2025
D-0214-2025Class IITimolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC LJanuary 23, 2025
D-0182-2025Class IICiprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, DistDecember 16, 2024
D-0114-2025Class IITimolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDCDecember 5, 2024
D-0035-2025Class IITimolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC LOctober 29, 2024
D-0642-2024Class IITimolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b)August 12, 2024
D-0623-2024Class IICiprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10)July 23, 2024
D-0632-2024Class IITimolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC LJuly 18, 2024
D-0488-2024Class IITimolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and bApril 25, 2024