FDA-Drug2022-03-30Class I
Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032-00), each vial: 100 mL fill in a 100 mL vial (NDC 63323-032-04), Rx Only, Fresenius Kabi, Lake Zurich, IL 60047
Fresenius Kabi USA, LLC
Hazard
Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.
Sold states
Nationwide USA
Affected count
118,040 vials
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032-00), each vial: 100 mL fill in a 100 mL vial (NDC 63323-032-04), Rx Only, Fresenius Kabi, Lake Zurich, IL 60047
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0750-2022Don't want to check this manually?
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