Fresenius Kabi announced the voluntary recall of 2 lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200mcg/50mL, 50mL fill in a 50mL vial due to the possibility of cross-contamination with lidocaine.
The 2 recalled lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, NDC Number 63323-671-50, include:
- Batch Number 6121853; Expiration Date 05/2021; Distributed between 6/3/2019 and 12/4/2019.
- Batch Number 6122207; Expiration Date 06/2021; Distributed between 3/12/2020 and 4/8/2020.
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. According to the Company, the administration of the recalled product “containing trace amounts of lidocaine to a patient with lidocaine allergy […] could result in anaphylaxis, a potentially life-threatening condition.”
The Company is notifying its distributors and customers by letter and asking customers and distributors to check their stock immediately. Any recalled product should be discontinued from distribution or dispensing, and returned to Fresenius Kabi. The recall letter and response form are available here.
At this time, the Company has not received any adverse event reports related to this recall. Adverse reactions may be reported to the FDA’s MedWatch program.
For more information regarding this recall, contact Fresenius Kabi at (866) 716-2459 or visit fresenius-kabi.com.