Reported Jul 27, 2022 · Terminated

8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syringe, packaged in 1 x 50 mL Pre-Filled…

Nephron Sterile Compounding Center 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: Nephron Sterile Compounding Center LLC · 4500 12th Street Ext · West Columbia, SC · 29172-3025

Is this the product you have?

  • 8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syringe, packaged in 1 x 50 mL Pre-Filled Syringe per carton, 30 x 1 syringe carton per case, Rx Only Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172
  • NDC69374-214-50
Lot codes and dates

15 of 15 products

Products covered by this recall
#Product as published
1SB2001B, Exp. 1/2/2023
2SB2001C, Exp. 1/2/2023
3SB2003A, Exp. 2/14/2023
4SB2003B, Exp. 2/14/2023
5SB2003C, Exp. 2/14/2023
6SB2004A, Exp. 3/1/2023
7SB2004B, Exp. 3/1/2023
8SB2004C, Exp. 3/1/2023
9SB2005A, Exp. 3/8/2023
10SB2007A, Exp. 3/22/2023
11SB2007B, Exp. 3/22/2023
12SB2008A, Exp. 3/29/2023
13SB2008B, Exp. 3/29/2023
14SB2009A, Exp. 4/5/2023
15SB2009B, Exp. 4/5/2023
Amount recalled
36,354 syringes

This recall covers 37 products

The agency filed one notice per product. You are reading one of them; the other 36 are below.

24 more are in the archive.

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 Jun 17, 2024 · Data as of Sep 19, 8:05 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.