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
Reported: March 30, 2022 Initiated: March 4, 2022 #D-0750-2022
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.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 118,040 vials
- Distribution
- Nationwide USA
- Location
- Lake Zurich, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Fresenius Kabi USA, LLC. Units affected: 118,040 vials.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Drug on March 30, 2022. Severity: Critical. Recall number: D-0750-2022.
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