Home / Recalls / FDC Limited / D-0403-2025

D-0403-2025 Class II Ongoing

Recalled by FDC Limited — Aurangabad, Maharashtra State, N/A

Recall Details

Product Type
Drugs
Report Date
May 14, 2025
Initiation Date
April 18, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
60428 bottles

Product Description

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-01.

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

U.S. Nationwide

Code Information

Lot #: 083I098, Exp. Date 08/31/2025

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-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-0182-2025 Class II — Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bo (December 16, 2024)
  • 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)