FDAHealthJuly 30, 2025
Exela Pharma Sciences LLC — 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 S
⚠️ Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 30, 2025
Nationwide in the USA
What's affected?
- Product
- 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)
- Brand
- SODIUM BICARBONATE
- Lot code
- 10004077
Additional details
Lot # 10004077, Exp. 02/28/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: N/A.
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