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

FDA recall notice · announced December 16, 2020 · Fresenius Kabi

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

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

Notes

Distribution: USA Nationwide
Lot/code information: Lot #: 6123925
Quantity: 13,525 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0120-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.