Drug product
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
D-1537-2020
Product summary
- Event
- Event 86095
- Status
- Terminated
- Classification
- Class I
- Quantity
- 25,100 bottles
- Official record key
drug-enforcement:D-1537-2020
Official wording
Reason: Cross Contamination with other products: trace amounts of lidocaine
Code information: Lot #: 6121853, Exp 05/2021; 6122207, Exp 06/2021
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Unknown
Cross Contamination with other products: trace amounts of lidocaine