July 22, 2020
Audience: Consumer, Health Professional, Pharmacy
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:
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 | 6121853 | 05/2021 | 06/03/2019 | 12/04/2019 |
6122207 | 06/2021 | 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. 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.
Source: FDA
Related Post
Mar
7 Health Benefits of Attending Concerts
Music resembles an embrace for your spirit. Music is quite possibly of the best gift we have on this planet. It assists us with communicating our feelings, it interfaces with others, and it could actually help us unwind and ease.
Read MoreMar
Why Are Cancer Rates Rising in Adults Under 50?
One of the most widely recognized risk factors for disease is something we can't hope to make any significant difference with age. Our disease risk increments as we age, with the typical age at conclusion drifting around 68. Yet, another concentrate.
Read MoreFeb
World Mental Health Day 2023
World Emotional wellness Day 2023 is a chance for individuals and networks to join behind the subject 'Psychological well-being is a general basic freedom" to further develop information, bring issues to light and drive activities that advance and safeguard everybody's.
Read MoreFeb
Benefits of Celery Juice: A Comprehensive Review Based on Scientific Research
In the first place, celery is brimming with supplements, like potassium, calcium, and nutrients, and is loaded with a plenty of cell reinforcements. As a matter of fact, a solitary stem of celery contains no less than 12 unique antioxidantsTrusted.
Read More