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 1 SB2001B, Exp. 1/2/2023 2 SB2001C, Exp. 1/2/2023 3 SB2003A, Exp. 2/14/2023 4 SB2003B, Exp. 2/14/2023 5 SB2003C, Exp. 2/14/2023 6 SB2004A, Exp. 3/1/2023 7 SB2004B, Exp. 3/1/2023 8 SB2004C, Exp. 3/1/2023 9 SB2005A, Exp. 3/8/2023 10 SB2007A, Exp. 3/22/2023 11 SB2007B, Exp. 3/22/2023 12 SB2008A, Exp. 3/29/2023 13 SB2008B, Exp. 3/29/2023 14 SB2009A, Exp. 4/5/2023 15 SB2009B, 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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