Product: POLYHEXAMETHYLENE BIGUANIDE 0.2MG/ML (0.2%) (10ML DROPTAINER) OPTH SOLUTION, 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