FDA Recall D-0023-2023
Exela Pharma Sciences LLC · Lenoir, NC
Class I — life-threatening Terminated 1102 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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 for recall
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Recall record
- Recall number
D-0023-2023- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide within the United States
- Recall initiated
- 2022-10-04
- Classified by FDA Center
- 2022-10-27
- FDA published
- 2022-11-02
- Terminated
- 2025-10-10
- Recalling firm
- Exela Pharma Sciences LLC
- Firm location
- Lenoir, NC