Reported Sep 2, 2020 · Terminated
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion,…
Fresenius Kabi USA, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Kabi USA, LLC · 3 Corporate Dr · Lake Zurich, IL · 60047-8930
Is this the product you have?
- 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
- Lot codes and dates
Lot #: 6121853Exp 05/20216122207Exp 06/2021
- Amount recalled
- 25,100 bottles
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Cross Contamination with other products: trace amounts of lidocaine
Using this product could cause serious injury, illness or death — stop using it now.
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