Class I โ€” Serious Health Hazard

Serious health hazard โ€” 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 Defective Container: Complaints received of vial breakage and...

Date: October 4, 2022
Company: Exela Pharma Sciences LLC
Status: Terminated
Source: FDA (Drug)

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 (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.

Quantity: 148,920

Why Was This Recalled?

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Exela Pharma Sciences LLC

Exela Pharma Sciences LLC has 12 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report