Sodium Acetate Injection — Class I drug recall D-0750-2022
Terminated recall by Fresenius Kabi USA, LLC, reported 2022-03-30, distributed nationwide. Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and tr
| Recall number | D-0750-2022 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2022-03-04 |
| Classified | 2022-04-06 |
| Reported by FDA | 2022-03-30 |
| Terminated | 2023-09-29 |
| Distributed | Nationwide (US) |
| Quantity | 118,040 vials |
| Reason classes | specification failure |
| NDC | 63323-0032, 63323-0032-00, 63323-0032-04 |
| Lot numbers | 6124193, 6124196, 6124226, 6124532, 6125333, 6125678, 6126846 |
| Expiration dates | 2022-05, 2022-06, 2022-12, 2023-01, 2023-08 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0750-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.