Class I
Terminated
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
This recall has been terminated (originally issued March 30, 2022).
- Company
- Fresenius Kabi Usa, Llc
- Recall Initiated
- March 4, 2022
- Posted
- March 30, 2022
- Recall Number
- D-0750-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 118,040 vials
- Firm Location
- Lake Zurich, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide USA
Lot / Code Info
Lot #: 6124193, 6124196, 6124226, Exp 05/2022; 6124532, Exp 06/2022; 6125333, Exp 12/2022; 6125678, Exp 01/2023; 6126846, Exp 08/2023
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