Drugplain

Dexmedetomidine 200 ug/2mL

Dexmedetomidine · INJECTION, SOLUTION · ProPharma Distribution

7 Recalls on RecordCurrently in Shortage
Plain English

Dexmedetomidine is a injection, solution containing dexmedetomidine at 200 ug/2mL, taken intravenous. Manufactured by ProPharma Distribution.

Key Facts

Brand Name
Dexmedetomidine
Generic Name
Dexmedetomidine
NDC Code (Product)
84549-230
Manufacturer
ProPharma Distribution
Strength
200 ug/2mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
ANDA202126
Marketing Start
01/19/2021

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 200 ug/2mL?

The NDC (National Drug Code) for Dexmedetomidine 200 ug/2mL is 84549-230, listed by ProPharma Distribution.