Product: Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volume (NDC 70360-017-38) and b) 10 mL Total Volume (NDC 70360-017-39) in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-017-38
Reason for recall: Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Recall initiated: 20160920
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated