US Drug Recall Register
Class I · High risk Terminated Initiated Mar 4, 2022 (5 years ago)

Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20…

Class I — High risk. Reasonable probability of serious harm or death.

Why it was 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.

What 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

Recalling firm
Fresenius Kabi USA, LLC
NDC code
63323-032-00
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0750-2022

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.