FDAFDA · Food and drugs·Recall number D-0369-2022
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1
Published January 19, 2022 · Recall initiated: January 11, 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
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Exela Pharma Sciences LLC
- Distributor
- Nationwide within the United States
- Lot
- Lot #: C0001088/P0001317, Exp. Date 08/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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