Product Safety Recalls

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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0750-2022
Event ID89725
BrandSODIUM ACETATE
Generic NameSODIUM ACETATE
ManufacturerSODIUM ACETATE
Original Package?1
Active SubstanceSODIUM ACETATE
Drug RouteINTRAVENOUS
DistributionNationwide USA
Quantity118,040 vials
Recall ReasonPresence 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 ClassificationClass I
Drug Code Info20220330
Product NDC63323-032
Recall Initiation Date20220304
Report Date20220330
Classification Date20220406
Address3 Corporate Dr
Lake Zurich, IL 60047-8930
United States
Recalling FirmFresenius Kabi USA, LLC
Initial Notification Letter
Unique Ingredient Identifier4550K0SC9B
Drug Application NumberANDA206687
Structured Product Labeling (SPL ID)9b00cb54-42d1-c928-e053-2995a90abda6
Structured Product Labeling (SPL Set ID)d7fabf08-d4e0-4bb5-8416-2e8ffe27c04b
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