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
Reason for recall: Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Recall initiated: 20240425
Status: Completed
Classification: Class II
Recall type: Voluntary: Firm initiated