FDAFDA · Food and drugs·Recall number D-0079-2023
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, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1.
Published December 21, 2022 · Recall initiated: November 28, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Brand
- SODIUM BICARBONATE
- Manufacturer
- Exela Pharma Sciences LLC
- Distributor
- Nationwide within the United States
- Lot
- Lots: P0001178 Exp. 05/2023; P0001298, P0001301, P0001313, P0001314, P0001317 Exp. 08/2023; P0001330, P0001464 Exp. 09/2023; P0001442 Exp. 11/2023; P0001467, P0001472, P0001486, P0001532 Exp. 12/2023.
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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