FDC Limited: Drug Recall

Recall #D-0488-2024 · 04/25/2024

Class II: Risk

Recall Details

Recall Number: D-0488-2024
Classification: Class II
Product Type: Drug
Recalling Firm: FDC Limited
Status: Completed
Date Initiated: 04/25/2024
Location: Aurangabad, Maharashtra State, N/A, India
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 382,104 units

Reason for Recall

Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.

Product Description

Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ

Distribution Pattern

New Jersey Only

Other Recalls by FDC Limited

Class II: Risk 07/05/2025

Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Class II: Risk 04/18/2025

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.
Class II: Risk 03/11/2025

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
Class II: Risk 01/23/2025

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.
Class II: Risk 12/16/2024

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

View all recalls by FDC Limited →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.