Sodium Chloride Injection Recalled Due To Cross-Contamination


Company Announcement Date:
November 19, 2020
FDA Publish Date:
November 19, 2020
Product Type:
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
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