Fresenius Kabi Issues Voluntary Nationwide Recall of a Single Lot of Dexmedetomidine Hydrochloride Injection Due to Cross-Contamination of Lidocaine

LAKE ZURICH, Ill.--(BUSINESS WIRE)-- Fresenius Kabi USA is voluntarily recalling a single lot of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg /mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to a trace amount of lidocaine present in the lot. This recall is being performed to the user level.

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Fresenius Kabi is voluntarily recalling one lot of Dexmedetomidine Hydrochloride Injection in 0.9% Sodium Chloride Injection, 200 mcg 50 mL (4 mcg mL), 50 mL fill in a 50 mL vial due to trace amounts of Lidocaine being present in the product. (Photo: Business Wire)

Fresenius Kabi is voluntarily recalling one lot of Dexmedetomidine Hydrochloride Injection in 0.9% Sodium Chloride Injection, 200 mcg 50 mL (4 mcg mL), 50 mL fill in a 50 mL vial due to trace amounts of Lidocaine being present in the product. (Photo: Business Wire)

To date, no adverse drug experience reports have been received for the recalled lot. Administration of Dexmedetomidine HCl containing trace amounts of lidocaine to a patient with lidocaine allergy could result in a potentially life-threatening allergic reaction.

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is approved for intravenous use and indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.

Listed below is a table of the recalled lot distributed nationwide to wholesalers, distributors, hospitals and pharmacies between April 9, 2020 and April 13, 2020. An image of the label is also included below.

Product Name/Product size

NDC Number

Product
Code

Batch
Number

Expiration
Date

First Ship
Date

Last Ship
Date

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL fill in a 50 mL vial

63323-671-50

671050

6123925

03/2022

04/09/2020

04/13/2020

Fresenius Kabi is notifying its distributors and customers by letter and asking them 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 any 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.

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

 
 

Source: Fresenius Kabi

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Fresenius Kabi is voluntarily recalling one lot of Dexmedetomidine Hydrochloride Injection in 0.9% Sodium Chloride Injection, 200 mcg 50 mL (4 mcg mL), 50 mL fill in a 50 mL vial due to trace amounts of Lidocaine being present in the product. (Photo: Business Wire)

View this news release and multimedia online at:
http://www.businesswire.com/news/home/20201119006215/en

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