July 2020 FDA Recall Dexmedetomidine Hydrochloride by Fresenius Kabi Usa, Llc
D-1537-2020 - Cross Contamination with other products
This Class I drug recall was voluntarily initiated by Fresenius Kabi Usa, Llc on July 22, 2020 for the product Dexmedetomidine Hydrochloride. The FDA reported the reason for recall as cross contamination with other products. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1537-2020
Cross Contamination with other products: trace amounts of lidocaine
07-22-2020
09-02-2020
25,100 bottles
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Fresenius Kabi USA, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S.A. Nationwide
09-12-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 63323-671-05
Batch or Lot Expiration Information
Lot# : 6121853, Exp 05/2021; 6122207, Exp 06/2021
