FDA-Drug2025-08-06Class II
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.
FDC Limited
Hazard
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Sold states
U.S Nationwide.
Affected count
154,176 bottles
Manufactured in
B-8 MIDC Industrial Area, Waluj District, Aurangabad, Maharashtra State, India
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0543-2025Don't want to check this manually?
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