Dexmedetomidine Hydrochloride Injection, Solution
FDA Recall NDC 63323-671
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Dexmedetomidine Hydrochloride (NDC 63323-671). A significant event, classified as Class I, was initiated on Nov 17, 2020 by Fresenius Kabi Usa, Llc. The reported reason for this action was: "Cross Contamination with other products: trace amounts of lidocaine"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
Cross Contamination with other products: trace amounts of lidocaine
Nov 17, 2020
Dec 16, 2020
13,525 bottles
Recall Profile & Regulatory Data
Event ID
86766
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Sep 12, 2022
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
Batch or Lot Expiration Information
Lot# : 6123925
Affected Packages Involved in this Recall
63323-671-02Product
63323-671-20Product
63323-671-05Product
63323-671-50Product
63323-671-01Product
63323-671-00Product
Class I Terminated
Cross Contamination with other products: trace amounts of lidocaine
Jul 22, 2020
Sep 02, 2020
25,100 bottles
Recall Profile & Regulatory Data
Event ID
86095
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Sep 12, 2022
Product Description
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
Batch or Lot Expiration Information
Lot# : 6121853, Exp 05/2021; 6122207, Exp 06/2021
Affected Packages Involved in this Recall
63323-671-02Product
63323-671-20Product
63323-671-05Product
63323-671-50Product
63323-671-01Product
63323-671-00Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
