Product: 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].
Reason for recall: Defective container; yellow colored spike from cap lodged in the nozzle
Recall initiated: 20240718
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated