SODIUM ACETATE Recall D-0750-2022
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
SODIUM ACETATE Recall D-0750-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0750-2022 |
| Event ID | 89725 |
| Brand | SODIUM ACETATE |
| Generic Name | SODIUM ACETATE |
| Manufacturer | SODIUM ACETATE |
| Original Package? | 1 |
| Active Substance | SODIUM ACETATE |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide USA |
| Quantity | 118,040 vials |
| Recall Reason | 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. |
| Drug Classification | Class I |
| Drug Code Info | 20220330 |
| Product NDC | 63323-032 |
| Recall Initiation Date | 20220304 |
| Report Date | 20220330 |
| Classification Date | 20220406 |
| Address | 3 Corporate Dr Lake Zurich, IL 60047-8930 United States |
| Recalling Firm | Fresenius Kabi USA, LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 4550K0SC9B |
| Drug Application Number | ANDA206687 |
| Structured Product Labeling (SPL ID) | 9b00cb54-42d1-c928-e053-2995a90abda6 |
| Structured Product Labeling (SPL Set ID) | d7fabf08-d4e0-4bb5-8416-2e8ffe27c04b |
| Similar To |