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Recall Observatory FDA recall evidence

Drug 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

D-0120-2021

November 17, 2020

Class I

Product summary

Firm
Fresenius Kabi USA, LLC
Event
Event 86766
Status
Terminated
Classification
Class I
Quantity
13,525 bottles
Official record key
drug-enforcement:D-0120-2021

Official wording

Reason: Cross Contamination with other products: trace amounts of lidocaine

Code information: Lot #: 6123925

Distribution pattern: USA Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Cross Contamination with other products: trace amounts of lidocaine