On March 7, 2022, Fresenius Kabi announced that it was recalling its Sodium Acetate Injection due to contamination. The recall states that particulate was discovered in certain lots of this Sodium Acetate Injection product. The recall affects seven lots of Sodium Acetate Injection, USP, 100 mL fill in a 100 mL and 400 mEq/100 mL (4 mEq/mL) vials. The affected lots were sold at the consumer level.
Elemental and microscopic examinations found the presence of particulates comprised of oxygen, carbon, iron, sodium, chromium, silicon, cellulose, and aluminum.
Administering injectable products containing particulate matter can lead to swelling, infection, and cardiac events such as damage to organs, stroke, blocked blood vessels in the lungs, heart, or brain, and death. These recalled lots were manufactured and sold in 2020 and 2021.
Sodium Acetate Injection, USP is used to correct or prevent low blood sodium. Patients use Sodium Acetate Injection as a source of sodium when they cannot consume sodium.
The recalled lots were distributed nationwide to distributors, wholesalers, pharmacies, and hospitals, from September 2020 until November 2021.
Fresenius Kabi USA is contacting its customers and distributors by letter. The company is urging its distributors and customers to check their stock and quarantine the use or distribution of the recalled products. Distributors are urged to contact their customers and ask them to quarantine the affected lots. The recall letter can be found at https://www.fresenius-kabi.com/us/pharmaceutical-product-updates. The recall is being carried out with the knowledge of the U.S. Food and Drug Administration.
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