Product: Mitomycin Preservative Free Irrigation, 40mg/10mL (4mg/mL), 10mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35, barcode 5 69623 16035 0.
Reason for recall: Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Recall initiated: 20190618
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated