Fresenius Kabi Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine Hydrochloride Injection Due to Cross-Contamination of Lidocaine

LAKE ZURICH, Ill., July 22, 2020 – Fresenius Kabi USA is voluntarily recalling two lots 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 the possibility of a trace amount of lidocaine present in these two lots and our investigation indicates that this issue is limited to these two product lots. This recall is being performed to the user level.

To date, no adverse drug experience reports have been received for either of the lots being recalled by Fresenius Kabi. Administration of Dexmedetomidine HCl containing trace amounts of lidocaine to a patient with lidocaine allergy, however, could result in anaphylaxis, a potentially life-threatening condition.

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 lots distributed nationwide to wholesalers, distributors, hospitals, and pharmacies between June 3, 2019 and April 8, 2020, as well as a copy of the label:

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 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.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax:
  • Download form www.fda.gov/MedWatch/getforms.html 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. Central Time 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.