FDA Recall D-0750-2022

Fresenius Kabi USA, LLC · Lake Zurich, IL

Class I — life-threatening Terminated 574 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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

Lot / code: Lot #: 6124193, 6124196, 6124226, Exp 05/2022; 6124532, Exp 06/2022; 6125333, Exp 12/2022; 6125678, Exp 01/2023; 6126846, Exp 08/2023

Quantity: 118,040 vials

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.

Recall record

Recall number: D-0750-2022
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide USA
Recall initiated: 2022-03-04
Classified by FDA Center: 2022-04-06
FDA published: 2022-03-30
Terminated: 2023-09-29
Recalling firm: Fresenius Kabi USA, LLC
Firm location: Lake Zurich, IL

Drug identification

Brand name(s): SODIUM ACETATE
Generic name(s): SODIUM ACETATE
Manufacturer(s): Fresenius Kabi USA, LLC
NDC(s): 63323-032
Route(s): INTRAVENOUS

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