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Class I: serious health riskTerminated

Fresenius Kabi Dexmedetomidine HCl in 0 Recall

Dexmedetomidine HCl in 0

Fresenius Kabi USA, LLC · Lake Zurich, IL

Risk level
Class I
Reported by FDA
Dec 16, 2020
Recall ID
D-0120-2021
Check your lot numberHow we source this data

Summary

Fresenius Kabi recalled Dexmedetomidine HCl in 0 starting Nov 17, 2020. The FDA classified it as Class I (serious health risk) and published enforcement report D-0120-2021 on Dec 16, 2020. Reason: Cross Contamination with other products: trace amounts of lidocaine. Status: Terminated.

Why it was recalled

Cross Contamination with other products: trace amounts of lidocaine

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

Lot numbers, UPCs & expiration codes

Lot #: 6123925

Where it was sold

USA Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0120-2021
Classification
Class I
Status
Terminated
Recall initiated
Nov 17, 2020
FDA report date
Dec 16, 2020
Quantity
13,525 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Fresenius Kabi USA, LLC

Original FDA data

Every field from FDA enforcement report D-0120-2021, exactly as published.

Show all FDA fields
City
Lake Zurich
State
IL
Status
Terminated
Country
United States
Event ID
86766
Address
3 Corporate Dr
Code information
Lot #: 6123925
Postal code
60047-8930
Report date
Dec 16, 2020
Product type
Drugs
Recall number
D-0120-2021
Classification
Class I
Recalling firm
Fresenius Kabi USA, LLC
Product quantity
13,525 bottles
Termination date
Sep 12, 2022
Reason for recall
Cross Contamination with other products: trace amounts of lidocaine
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
USA Nationwide
Recall initiation date
Nov 17, 2020
Initial firm notification
Letter
Center classification date
Dec 8, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0120-2021, published Dec 16, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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