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
Reported: December 16, 2020 Initiated: November 17, 2020 #D-0120-2021
Product Description
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
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 13,525 bottles
- Distribution
- USA Nationwide
- Location
- Lake Zurich, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Fresenius Kabi USA, LLC. Units affected: 13,525 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 December 16, 2020. Severity: Critical. Recall number: D-0120-2021.
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