FDA-Drug2022-12-21Class I
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
Exela Pharma Sciences LLC
Hazard
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Sold states
Nationwide within the United States
Affected count
37,320 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 Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0080-2023Don't want to check this manually?
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