Premier Pharmacy Labs Inc recalls Sodium Bicarbonate INJ 8.4%, 50 mEq/50mL (84mg/mL) (1mEq/mL), 50mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Com
Recalled July 3, 2019 · FDA recall D-1426-2019 · 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
13150 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
Sodium Bicarbonate INJ 8.4%, 50 mEq/50mL (84mg/mL) (1mEq/mL), 50mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-232-39, barcode 8 69623 23239 3.
Manufacturer(s)
Premier Pharmacy Labs Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →