FDA-Drug2022-06-08Class II
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
Nephron Sterile Compounding Center LLC
Hazard
Lack of Assurance of Sterility
Sold states
Nationwide in the USA
Affected count
13612 syringes
Manufactured in
4500 12th Street Ext, N/A, West Columbia, SC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0950-2022Don't want to check this manually?
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