Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032
Summary
The FDA issued a Class I for Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 tray by Fresenius Kabi USA, LLC. Reason: Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium.
Details
Source
Drug Recall
External ID
D-0750-2022
Action Date
2022-03-30
Status
Terminated
Category
drug
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
Lot/Code Info: Lot #: 6124193, 6124196, 6124226, Exp 05/2022; 6124532, Exp 06/2022; 6125333, Exp 12/2022; 6125678, Exp 01/2023; 6126846, Exp 08/2023
Quantity Affected: 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.
Distribution
Nationwide USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-04
Company
Lake Zurich, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 78 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Fresenius Kabi USA, LLC has 46 FDA actions in our database, including 46 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fresenius Kabi USA, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fresenius Kabi USA, LLC have FDA actions?
Fresenius Kabi USA, LLC has 46 FDA actions in our database, including 46 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0750-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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