FDA-Drug2022-01-19Class II
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1
Exela Pharma Sciences LLC
Hazard
Lack of Assurance of Sterility
Sold states
Nationwide within the United States
Affected count
18,960 vials
Manufactured in
1245 Blowing Rock Blvd, N/A, Lenoir, NC, United States
Products
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0369-2022Don't want to check this manually?
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