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FDARecalled Aug 6, 2025 · #D-0543-2025

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 Je...

Hazard

Class II — temporary health risk

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Description

Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle. Classification: Class II Distribution: U.S Nationwide.

Product details

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.
Type
Drugs
Manufacturer
FDC Limited
Model numbers
083L061
UPCs