FDA-Drug2025-02-12Class 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: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Sold states
Distributed to one (1) Us Distributor in NJ
Affected count
118104 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-0214-2025Don't want to check this manually?
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