Reported Jun 8, 2022 · Terminated
8.4% Sodium Bicarbonate Injection, USP, 1 mEq/mL, 4.2 g/50 mL (84 mg/mL), 1 x 50 mL Pre-Filled Syringe, packaged in a)…
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 InjectionUSP1 mEq/mL4.2 g/50 mL (84 mg/mL)1 x 50 mL Pre-Filled Syringepackaged in a) 10 x 1 syringe cartonb) 30 x 1 syringe cartonRx OnlyNephron 503B outsourcing facility4500 12th St. ExtensionWest ColumbiaSC 29172
- NDC69374-214-50
- Lot codes and dates
- Lots
SB2001AExp. 1/2/2023SB2005BSB2005CExp. 3/8/2023SB2006ASB2006BSB2006CExp. 3/16/2023
- Lots
- Amount recalled
- 13612 syringes
This recall covers 20 products
The agency filed one notice per product. You are reading one of them; the other 19 are below.
7 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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