Class II Recall

FDC Limited

Product
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.
Reason
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Classification
Class II
Status
Ongoing
Lot
Lot#: 083L061, Exp.: 11/2025.
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.
FDC Limited — Class II Recall | MedicineWatch US