FDA Recall D-0120-2021
Fresenius Kabi USA, LLC · Lake Zurich, IL
Class I — life-threatening Terminated 664 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 / 50 mL (4 mcg / mL), 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-0120-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- USA Nationwide
- Recall initiated
- 2020-11-17
- Classified by FDA Center
- 2020-12-08
- FDA published
- 2020-12-16
- 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