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
Reported: September 2, 2020 Initiated: July 22, 2020 #D-1537-2020
Product Description
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
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 25,100 bottles
- Distribution
- U.S.A. Nationwide
- Location
- Lake Zurich, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Fresenius Kabi USA, LLC. Units affected: 25,100 bottles.
Why was this product recalled? ▼
Cross Contamination with other products: trace amounts of lidocaine
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 2, 2020. Severity: Critical. Recall number: D-1537-2020.
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