Drugplain

Dexmedetomidine 100 ug/mL

Dexmedetomidine · INJECTION, SOLUTION · Eugia US LLC

7 Recalls on RecordCurrently in Shortage
Plain English

Dexmedetomidine is a injection, solution containing dexmedetomidine at 100 ug/mL, taken intravenous. Manufactured by Eugia US LLC.

Key Facts

Brand Name
Dexmedetomidine
Generic Name
Dexmedetomidine
NDC Code (Product)
55150-209
Manufacturer
Eugia US LLC
Strength
100 ug/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
ANDA205867
Marketing Start
03/17/2016

Recall History

7 Recalls on Record
Class II04/13/2022

Mckesson Medical-Surgical Inc. Corporate Office

cGMP deviations: Temperature abuse

TerminatedVoluntary: Firm initiated
Class II04/12/2019

CMC Enterprise Pharmacy

Lack of sterility assurance.

TerminatedVoluntary: Firm initiated
Class I07/22/2020

Fresenius Kabi USA, LLC

Cross Contamination with other products: trace amounts of lidocaine

TerminatedVoluntary: Firm initiated
Class II03/31/2025

Denver Solutions, LLC DBA Leiters Health

Lack of Assurance of Sterility: Leaking/damaged syringes.

OngoingVoluntary: Firm initiated
Class II02/22/2017

Advanced Pharma Inc.

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

TerminatedVoluntary: Firm initiated
Class II11/14/2014

Attix Pharmaceuticals

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

TerminatedVoluntary: Firm initiated
Class I11/17/2020

Fresenius Kabi USA, LLC

Cross Contamination with other products: trace amounts of lidocaine

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is Dexmedetomidine used for?

Dexmedetomidine contains Dexmedetomidine. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is Dexmedetomidine a controlled substance?

Dexmedetomidine is not classified as a controlled substance by the DEA.

What is the generic name for Dexmedetomidine?

The generic name for Dexmedetomidine is Dexmedetomidine. There are 11 other brand versions of Dexmedetomidine.

What is the NDC code for Dexmedetomidine 100 ug/mL?

The NDC (National Drug Code) for Dexmedetomidine 100 ug/mL is 55150-209, listed by Eugia US LLC.