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FDAOctober 4, 2022drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration

What to do

FDA enforcement status: Terminated

Brands named

exela pharma sciencesexelaexela pharma

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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