FDA-Drug2020-12-16Class I
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
Hazard
Cross Contamination with other products: trace amounts of lidocaine
Sold states
USA Nationwide
Affected count
13,525 bottles
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0120-2021More Fresenius Kabi USA, LLC recalls
- FDA-Drug2026-06-17Fresenius Kabi epinephrine injection recalled for failed impurity specifications
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility assurance
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility assurance
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility concerns
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for lack of sterility assurance
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