Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
8.4% Sodium Bicarbonate Injection Recalled by Exela Pharma Sciences LLC Due to Presence of Particulate Matter: Silicone
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Exela Pharma Sciences LLC directly.
Affected Products
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b) 25x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-4), For Intravenous Use Only, RX Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645; ALSO LABELED 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), c) 20x50 mL Single Dose Vials, (Vial NDC 72572-740-01; Carton NDC 72572-740-20), Rx Only, Mfd for: Civica, Inc., Lehi, Utah, 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.
Quantity: 355,220 vials
Why Was This Recalled?
Presence of Particulate Matter: Silicone
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Exela Pharma Sciences LLC
Exela Pharma Sciences LLC has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report