Fresenius Kabi USA Dexmedetomidinhydrochlorid Injektion, 200 mcg/50 ml - zurückgerufen durch Kreuzkontamination mit Lidocain, USA

United States

Company name: Fresenius Kabi USA
Brand name: Fresenius Kabi
Product recalled: Dexmedetomidine Hydrochloride Injection, 200 mcg/50 mL
Reason of the recall: Cross contamination with lidocaine
FDA Recall date: July 22, 2020
Recall details: 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. Below there is a list 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:

Product Name/Product size: Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL fill in a 50 mL vial
NDC Number: 63323-671-50
Product Code: 671050
Batch Number: 6121853 - 6122207
Expiration Date: 05/2021 - 06/2021
First Ship Date 06/03/2019 - 12/04/2019
Last Ship Date: 03/12/2020 - 04/08/2020

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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-two-lots-dexmedetomidine-hydrochloride-injection

Source: FDA