Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: F...
FDA Recall #D-0403-2025 — Class II — April 18, 2025
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.
Recalling Firm
FDC Limited — Aurangabad, Maharashtra State, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
60428 bottles
Distribution
U.S. Nationwide
Code Information
Lot #: 083I098, Exp. Date 08/31/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated