Premier Pharmacy Labs Inc recalls Mitomycin Preservative Free Irrigation, 40mg/10mL (4mg/mL), 10mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Wa
Recalled July 3, 2019 · FDA recall D-1420-2019 · Premier Pharmacy Labs
Hazard
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. · FDA Class II
Units
1834 irrigation vials
Sold at
Nationwide in the USA
Description
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.
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.
Manufacturer(s)
Premier Pharmacy Labs Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →