Class II
Ongoing
4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645 USA, NDC 51754-5012-1 (vial); 51754-5012-4 (carton)
This recall is currently active, issued September 17, 2025. It was issued by Exela Pharma Sciences Llc.
- Company
- Exela Pharma Sciences Llc
- Recall Initiated
- July 30, 2025
- Posted
- September 17, 2025
- Recall Number
- D-0620-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Lenoir, NC, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Distribution
Nationwide in the USA
Lot / Code Info
Lot # 10004077, Exp. 02/28/2026
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