FDAFDA · Food and drugs·Recall number D-1537-2020
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
Published September 2, 2020 · Recall initiated: July 22, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Cross Contamination with other products: trace amounts of lidocaine
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Fresenius Kabi USA, LLC
- Distributor
- U.S.A. Nationwide
- Lot
- Lot #: 6121853, Exp 05/2021; 6122207, Exp 06/2021
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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