Product: 5-Fluorouracil 1%, 2.5ML droptainer, and 5ML droptainer Ophthalmic, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason for recall: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Recall initiated: 20221222
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated