FDAFDA · Food and drugs·Recall number D-0023-2023
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, 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.
Published November 2, 2022 · Recall initiated: October 4, 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 · Letter
Recall details
- Manufacturer
- Exela Pharma Sciences LLC
- Distributor
- Nationwide within the United States
- Lot
- Lot #: P0001497 Exp. 12/2023; P0001600 Exp. 02/2024; P0001663 Exp. 03/2024
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.