Class II
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 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
This recall has been terminated (originally issued July 27, 2022).
- Recall Initiated
- June 30, 2022
- Posted
- July 27, 2022
- Recall Number
- D-1279-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 36,354 syringes
- Firm Location
- West Columbia, SC, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility
Distribution
Nationwide in the USA
Lot / Code Info
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
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