Fresenius Kabi announced another voluntary recall of a single lot of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200mcg/50mL, 50mL fill in a 50mL vial due to cross-contamination with lidocaine.

The recalled lot of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, NDC Number 63323-671-50, includes:

  • Batch Number 6123925; Expiration Date 03/2022; Distributed between 4/9/2020 and 4/13/2020.

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection is indicated for the sedation of nonintubated patients prior to and/or during surgical and other procedures. Administration of the recalled product to a patient with lidocaine allergy could potentially result in anaphylaxis if trace amounts of lidocaine are present.

At this time, the Company has not received any adverse event reports related to this recall. Adverse reactions related to this recall should be reported to the FDA’s MedWatch program.


Continue Reading

For more information, contact Fresenius Kabi at (866) 716-2459 or visit fresenius-kabi.com.

Reference

Fresenius Kabi issues voluntary nationwide recall of a single lot of dexmedetomidine hydrochloride injection due to cross-contamination of lidocaine. [press release]. November 19, 2020.