Reported Jan 19, 2022 · Terminated

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by:…

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)
    • 50 mL vials
    • Rx Only
  • Manufactured and Distributed byExela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1
Lot codes and dates
    • Lot #: C0001088/P0001317
    • Exp. Date 08/2023
Amount recalled
18,960 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Dec 2, 2022 · Data as of Sep 19, 7:23 PM UTC

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