Summary
- Company Announcement Date:
- November 19, 2020
- FDA Publish Date:
- November 19, 2020
- Product Type:
- Drugs
- Reason for Announcement:
-
Cross Contamination with Lidocaine
- Company Name:
- Fresenius Kabi USA
- Brand Name:
-
Fresenius Kabi USA
- Product Description:
-
Dexmedetomidine HCL in 0.9% Sodium Chloride Injection
Company Announcement
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.
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.
Read the full report here
As published by HealthyExaminer.com
