Class II Recall

FDC Limited

Product
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
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.
Classification
Class II
Status
Ongoing
Lot
Lot #: 083I006, Exp 08/31/2025
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.