Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: ...
FDA Recall #D-0114-2025 — Class II — December 5, 2024
Product Description
Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-513-15.
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
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
5184 bottles
Distribution
Distributed to one Us Distributor in NJ.
Code Information
Lot #: 083I006, Exp 08/31/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated