FDA Recall D-1537-2020
Fresenius Kabi USA, LLC · Lake Zurich, IL
Class I — life-threatening Terminated 782 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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
Reason for recall
Cross Contamination with other products: trace amounts of lidocaine
Recall record
- Recall number
D-1537-2020- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- U.S.A. Nationwide
- Recall initiated
- 2020-07-22
- Classified by FDA Center
- 2020-08-21
- FDA published
- 2020-09-02
- Terminated
- 2022-09-12
- Recalling firm
- Fresenius Kabi USA, LLC
- Firm location
- Lake Zurich, IL
Drug identification
- Brand name(s)
- DEXMEDETOMIDINE HYDROCHLORIDE
- Generic name(s)
- DEXMEDETOMIDINE HYDROCHLORIDE
- Manufacturer(s)
- Fresenius Kabi USA, LLC
- NDC(s)
63323-671- Route(s)
- INTRAVENOUS