Home / Recalls / FDC Limited / D-0182-2025

D-0182-2025 Class II Ongoing

Recalled by FDC Limited — Aurangabad, Maharashtra State

Recall Details

Product Type
Drugs
Report Date
January 15, 2025
Initiation Date
December 16, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
136,181 bottles

Product Description

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

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

Distribution Pattern

Nationwide

Code Information

Lot: 083L111, Exp. 11/30/2025; 084A032, Exp. 12/31/2025

Other recalls by FDC Limited

  • D-0543-2025 Class II — Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Ma (July 5, 2025)
  • D-0403-2025 Class II — Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, M (April 18, 2025)
  • D-0282-2025 Class II — Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx (March 11, 2025)
  • D-0214-2025 Class II — Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Ma (January 23, 2025)
  • D-0114-2025 Class II — Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, (December 5, 2024)
  • D-0035-2025 Class II — Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Ma (October 29, 2024)
  • D-0642-2024 Class II — Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 6 (August 12, 2024)
  • D-0623-2024 Class II — Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 m (July 23, 2024)
  • D-0632-2024 Class II — Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Ma (July 18, 2024)
  • D-0488-2024 Class II — Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC (April 25, 2024)