D-0750-2022 Class I Terminated
FDA drug recall D-0750-2022 was initiated by Fresenius Kabi USA, LLC on Mar 4, 2022 and is designated Class I. 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. The recall status is terminated (terminated Sep 29, 2023). Affected quantity: 118,040 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 30, 2022
- Initiation Date
- Mar 4, 2022
- Termination Date
- Sep 29, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 118,040 vials
Product Description
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
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 Pattern
Nationwide USA
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0750-2022
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026