FDAFDA · Food and drugs·Recall number D-1279-2022
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, NDC: 69374-214-50
Published July 27, 2022 · Recall initiated: June 30, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Distributor
- Nationwide in the USA
- Lot
- Lots: SB2001B, Exp. 1/2/2023; SB2001C, Exp. 1/2/2023; SB2003A, Exp. 2/14/2023; SB2003B, Exp. 2/14/2023; SB2003C, Exp. 2/14/2023; SB2004A, Exp. 3/1/2023; SB2004B, Exp. 3/1/2023; SB2004C, Exp. 3/1/2023; SB2005A, Exp. 3/8/2023; SB2007A, Exp. 3/22/2023; SB2007B, Exp. 3/22/2023; SB2008A, Exp. 3/29/2023; SB2008B, Exp. 3/29/2023; SB2009A, Exp. 4/5/2023; SB2009B, Exp. 4/5/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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