FDA-Drug2024-05-15Class II
Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ
FDC Limited
Hazard
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Sold states
New Jersey Only
Affected count
382,104 units
Manufactured in
B-8 MIDC Industrial Area, Waluj District, Aurangabad, Maharashtra State, N/A, India
Products
Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0488-2024Don't want to check this manually?
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