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Exela Pharma Sciences LLC Recall: 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 m

Exela Pharma Sciences LLC Recall: 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 m is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Exela Pharma Sciences LLC; Product: 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of

Recalling firmExela Pharma Sciences LLC
Product8.4% 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 for recallDefective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
ClassificationClass I (most serious — reasonable probability of serious health consequences or death)
StatusTerminated
DistributionNationwide within the United States
Recall initiated20221128
Recall numberD-0080-2023
Categorydrug
StateNC
CountryUnited States

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