CLASS I Drug recall · Reported 30 Mar 2022 · FDA Enforcement Report
Sodium Acetate Injection, USP, 400 mEq / (4 mEq / mL) recalled
Fresenius Kabi USA is recalling Sodium Acetate Injection, USP, 400 mEq / (4 mEq / mL), distributed nationwide in the US. The recall was initiated on 4 Mar 2022 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0750-2022
- FDA event ID
- 89725
- Recalling firm
- Fresenius Kabi USA, Lake Zurich, IL
- Brand
- Sodium Acetate
- Manufacturer
- Fresenius Kabi USA, LLC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 4 Mar 2022
- FDA classified
- 6 Apr 2022
- Reported
- 30 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 4 Mar 2022 | Recall initiated by company | |
| 30 Mar 2022 | Published in enforcement report | +26 days |
| 6 Apr 2022 | Classified by FDA | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #: 6124193, 6124196, 6124226, Exp 05/2022; 6124532, Exp 06/2022; 6125333, Exp 12/2022; 6125678, Exp 01/2023; 6126846, Exp 08/2023
Where was it sold?
Nationwide USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fresenius Kabi USA
All 94| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Tyenne (tocilizumab-aazg) Injection, 400 mg/ (20 mg/mL) vial recalledTyenne | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS I | Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate | Fresenius Kabi USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Glycopyrrolate Injection, USP, 1 mg per (0.2 mg per mL) recalledGlycopyrrolate | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
Other Sodium recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sodium Citrate 4%, Anticoagulation Solution Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Sodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. vial recalled | KRS Global Biotechnology | Sterility | Nationwide |
| Drug | CLASS II | Sodium Citrate 4%, 40 mg/mL syringe, Flush Syringe, Made recalled | CMC Enterprise Pharmacy | Sterility | NC |
| Drug | CLASS II | Sodium Acetate Injection, USP, 40 mEq recalled by HospiraSodium Acetate | Hospira | Sterility | Nationwide |