FDC Limited: Drug Recall

Recall #D-0642-2024 · 08/12/2024

Class II: Risk

Recall Details

Recall Number: D-0642-2024
Classification: Class II
Product Type: Drug
Recalling Firm: FDC Limited
Status: Ongoing
Date Initiated: 08/12/2024
Location: Aurangabad, Maharashtra State, India
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 176,784 bottles

Reason for Recall

Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

Product Description

Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey

Distribution Pattern

Nationwide U.S.A.

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.