Reported Sep 17, 2025 · 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…
Exela Pharma Sciences LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Exela Pharma Sciences LLC · 1245 Blowing Rock Blvd · Lenoir, NC · 28645-3618
Is this the product you have?
- 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 byExela Pharma Sciences, LLC, Lenoir, NC 28645 USA, NDC 51754-5012-1 (vial); 51754-5012-4 (carton)
- Lot codes and dates
Lot # 10004077Exp. 02/28/2026
- Amount recalled
- N/A
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
This product could cause temporary or reversible health problems — stop using it.
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