Nephron Sterile Compounding Center LLC recalls 8.4% Sodium Bicarbonate Injection, USP, 1 mEq/mL, 4.2 g/50 mL (84 mg/mL), 1 x 50 mL Pre-Filled Syringe, packaged in a) 1
Recalled June 8, 2022 · FDA recall D-0950-2022 · Nephron Sterile Compounding Center
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
13612 syringes
Sold at
Nationwide in the USA
Description
Lack of Assurance of Sterility
Product
8.4% Sodium Bicarbonate Injection, USP, 1 mEq/mL, 4.2 g/50 mL (84 mg/mL), 1 x 50 mL Pre-Filled Syringe, packaged in a) 10 x 1 syringe carton, b) 30 x 1 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-214-50
Manufacturer(s)
Nephron Sterile Compounding Center LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →