Reported Apr 2, 2025 · Ongoing
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For…
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?
- 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only
- Manufactured byExela Pharma Sciences, LLC, Lenoir, NC 28645
- NDC Inner Vial51754-5001-1
- NDC Carton51754-5001-4
- Lot codes and dates
- Lots
10006417 and 10006418Exp. 11/30/2026
- Lots
- Amount recalled
- 103,950 vials
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility
This product could cause temporary or reversible health problems — stop using it.
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