Premier Pharmacy Labs Inc recalls Dexamethasone Sodium Phosphate Preservative Free Sterile Solution for INJ, 24mg/mL, 1mL Sterile Single-Use Syringe, Rx o
Recalled July 3, 2019 · FDA recall D-1414-2019 · 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
86 syringes
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
Dexamethasone Sodium Phosphate Preservative Free Sterile Solution for INJ, 24mg/mL, 1mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-252-10, barcode 0 69623 25210 4.
Manufacturer(s)
Premier Pharmacy Labs Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →