Recalls / Class I
Class ID-1537-2020
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Brand name
- Dexmedetomidine Hydrochloride
- Generic name
- Dexmedetomidine Hydrochloride
- Active ingredient
- Dexmedetomidine Hydrochloride
- Route
- Intravenous
- NDC
- 63323-671
- FDA application
- ANDA208129
- Affected lot / code info
- Lot #: 6121853, Exp 05/2021; 6122207, Exp 06/2021
Why it was recalled
Cross Contamination with other products: trace amounts of lidocaine
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 3 Corporate Dr, N/A, Lake Zurich, Illinois 60047-8930
Distribution
- Quantity
- 25,100 bottles
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2020-07-22
- FDA classified
- 2020-08-21
- Posted by FDA
- 2020-09-02
- Terminated
- 2022-09-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1537-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.