LAKE ZURICH, Ill.–(BUSINESS WIRE)–Fresenius Kabi USA is voluntarily recalling seven lots of Sodium Acetate Injection, USP, 400 mEq/100 mL (4 mEq/mL), 100 mL fill in a 100 mL vial to the user level due to the presence of particulate matter found in reserve and/or stability sample vials. Microscopic and elemental analyses determined the presence of particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.
The administration of an injectable product that contains particulate matter may result in local irritation or swelling or infection in response to the foreign material. If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. To date, no adverse event reports have been received for these recalled lots, which were produced and sold in 2020 and 2021.
Sodium Acetate Injection, USP is indicated as a source of sodium, for addition to large volume IV fluids to prevent or correct low blood sodium levels in patients with restricted or no oral intake. It is also useful as an additive for preparing specific IV fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. Listed below is a table of the recalled lots distributed nationwide to wholesalers, distributors, hospitals, and pharmacies between September 2020 and November 2021. An image of the product packaging is also included below.
|
Product Name/Product size |
NDC Number |
Product |
Batch |
Expiration |
First Ship |
Last Ship |
|
Sodium Acetate Injection, USP, 400 mEq/ 100 mL (4 mEq/mL), 100 mL fill in a 100 mL vial |
63323-032-00 |
322100 |
6124193 |
05/2022 |
09/08/2020 |
12/22/2020 |
|
6124196 |
05/2022 |
11/16/2020 |
01/27/2021 |
|||
|
6124226 |
05/2022 |
12/22/2020 |
03/22/2021 |
|||
|
6124532 |
06/2022 |
01/27/2021 |
04/13/2021 |
|||
|
6125333 |
12/2022 |
04/06/2021 |
06/01/2021 |
|||
|
6125678 |
01/2023 |
06/23/2021 |
09/27/2021 |
|||
|
6126846 |
08/2023 |
10/07/2021 |
11/17/2021 |
Fresenius Kabi is notifying its distributors and customers by letter and asking customers and distributors to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product. Distributors should notify their customers and direct them to quarantine and discontinue distributing or dispensing the affected lots, and to return the product to Fresenius Kabi. The recall letter and response form are available at https://www.fresenius-kabi.com/us/pharmaceutical-product-updates.
Customers with questions regarding this recall may contact Fresenius Kabi at 1-866-716-2459 Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Time. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
-
Regular Mail or Fax:
Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178. -
Or, contact Fresenius Kabi at 1-800-551-7176, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. or via email at:
productcomplaint.USA@fresenius-kabi.com or
adverse.events.USA@fresenius-kabi.com
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
About Fresenius Kabi
Fresenius Kabi (www.fresenius-kabi.com/us) is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. For more information about Fresenius Kabi worldwide, please visit www.fresenius-kabi.com.
Contacts
Matt Kuhn, (847) 550-5751
matt.kuhn@fresenius-kabi.com