Drug product
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
D-0750-2022
Product summary
- Event
- Event 89725
- Status
- Terminated
- Classification
- Class I
- Quantity
- 118,040 vials
- Official record key
drug-enforcement:D-0750-2022
Official wording
Reason: 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.
Code information: Lot #: 6124193, 6124196, 6124226, Exp 05/2022; 6124532, Exp 06/2022; 6125333, Exp 12/2022; 6125678, Exp 01/2023; 6126846, Exp 08/2023
Distribution pattern: Nationwide USA
Derived failure modes
-
Foreign material or chemical contamination
particulate matter