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.
Reason
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Classification
Class I
Status
Terminated
Lot
Lot: P0001490 Exp. 12/2023
Date
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