Sodium Acetate Injection, Solution, Concentrate
FDA Recall NDC 63323-032
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Sodium Acetate (NDC 63323-032). A significant event, classified as Class I, was initiated on Mar 04, 2022 by Fresenius Kabi Usa, Llc. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
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.
Mar 04, 2022
Mar 30, 2022
118,040 vials
Recall Profile & Regulatory Data
Event ID
89725
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Termination Date
Sep 29, 2023
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
Batch or Lot Expiration Information
Lot# : 6124193, 6124196, 6124226, Exp 05/2022; 6124532, Exp 06/2022; 6125333, Exp 12/2022; 6125678, Exp 01/2023; 6126846, Exp 08/2023
Affected Packages Involved in this Recall
63323-032-04Product
63323-032-00Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
