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FDARecalled May 15, 2024 · #D-0488-2024

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, Di...

Hazard

Class II — temporary health risk

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Description

Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers. Classification: Class II Distribution: New Jersey Only

Product details

Product
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
Type
Drugs
Manufacturer
FDC Limited
Model numbers
UPCs