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Fresenius Kabi is voluntarily recalling 7 lots of Sodium Acetate Injection, USP, 400mEq/100mL (4mEq/mL), 100mL fill in a 100mL vial to the user level due to the presence of particulate matter found in reserve and/or stability sample vials.
Sodium Acetate Injection is indicated as a source of sodium, for addition to large volume intravenous (IV) fluids to prevent or correct low blood sodium levels in patients with restricted or no oral intake. It can also be used as an additive for preparing specific IV fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.
The recalled lots of Sodium Acetate Injection, USP, 400mEq/100mL (4mEq/mL), 100mL fill in a 100mL vial; NDC Number 63323-032-00; Product Code 322100, were distributed nationwide between September 2020 and November 2021, and include the following:
- Batch Number 6124193; Expiration Date 05/2022; First Ship Date 09/08/2020 and Last Ship Date 12/22/2020;
- Batch Number 6124196; Expiration Date 05/2022; First Ship Date 11/16/2020 and Last Ship Date 01/27/2021;
- Batch Number 6124226; Expiration Date 05/2022; First Ship Date 12/22/2020 and Last Ship Date 03/22/2021;
- Batch Number 6124532; Expiration Date 06/2022; First Ship Date 01/27/2021 and Last Ship Date 04/13/2021;
- Batch Number 6125333; Expiration Date 12/2022; First Ship Date 04/06/2021 and Last Ship Date 06/01/2021;
- Batch Number 6125678; Expiration Date 01/2023; First Ship Date 06/23/2021 and Last Ship Date 09/27/2021;
- Batch Number 6126846; Expiration Date 08/2023; First Ship Date 10/07/2021 and Last Ship Date 11/17/2021.
Administration of an IV product containing particulate matter may cause local irritation, swelling, or infection, and may cause stroke and potentially death if the particulate matter reaches the blood vessels. To date, the Company has not received reports of any adverse events related to this recall.
Adverse reactions or quality problems should be reported to the Food and Drug Administration’s MedWatch program.
For more information regarding this recall contact Fresenius Kabi at (866) 716-2459.
Reference
Fresenius Kabi issues voluntary recall of Sodium Acetate Injection, USP due to the presence of particulate matter. News release. Fresenius Kabi USA. Accessed March 7, 2022. https://www.businesswire.com/news/home/20220304005573/en/%C2%A0Fresenius-Kabi-Issues-Voluntary-Recall-of-Sodium-Acetate-Injection-USP-Due-to-the-Presence-of-Particulate-Matter
