Recall D-0543-2025

US Class II Ongoing · initiated 2025-07-05

Recalling firm

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 for recall

Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.

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