FDA-Drug2024-08-28Class II
Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey
FDC Limited
Hazard
Defective Container: patients are 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
Nationwide U.S.A.
Affected count
176,784 bottles
Manufactured in
B-8 MIDC Industrial Area, Waluj District, Aurangabad, Maharashtra State, India
Products
Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0642-2024Don't want to check this manually?
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