Fresenius Kabi is a global health care company that produces and specializes in medication and infusion/transfusion technology. Fresenius Kabi USA voluntarily recalled seven lots of Sodium Acetate Injection on Monday, March 7th. Various amounts of iron, sodium, silicon, chromium, aluminum and cellulose found in these injections led to seven lots being recalled. The presence of particular matter was found in the reserve and/or stability sample vials.
When particular matter is injected into a body, many things could happen—local irritation of the injection, swelling or infection are very possible when injected with particulate matter. If the particulate matter from the injection reaches a blood vessel, it can travel to various organs, causing blood flow blockage to the heart, lungs or brain. Any of these incidents could lead to a stroke or death.
A healthcare company who specializes in medicine needed to recall seven lots due to particular matter in their solution for injection. Was USP <790> and <1790> Visual Inspection process used? Was data integrity violated?
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