Drugplain

Methylene Blue 5 mg/mL

METHYLENE BLUE · INJECTION, SOLUTION · OLIC (Thailand) Limited

10 Recalls on Record
Plain English

Methylene Blue is a injection, solution containing methylene blue at 5 mg/mL, taken intravenous. Manufactured by OLIC (Thailand) Limited.

Key Facts

Brand Name
Methylene Blue
Generic Name
METHYLENE BLUE
NDC Code (Product)
15243-344
Manufacturer
OLIC (Thailand) Limited
Strength
5 mg/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
ANDA217561
Marketing Start
02/01/2025

Recall History

10 Recalls on Record
Class II05/17/2018

Guardian Pharmacy Services

Lack of sterility assurance.

TerminatedVoluntary: Firm initiated
Class II07/30/2025

GenoGenix LLC

Lack of Assurance of Sterility

OngoingVoluntary: Firm initiated
Class II11/16/2017

KRS Global Biotechnology, Inc

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

TerminatedVoluntary: Firm initiated
Class II10/24/2016

Burel Pharmaceuticals Inc

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

TerminatedVoluntary: Firm initiated
Class II07/24/2020

Vilvet Pharmaceuticals Inc.

cGMP deviations

TerminatedVoluntary: Firm initiated
Class II10/24/2016

Burel Pharmaceuticals Inc

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

TerminatedVoluntary: Firm initiated
Class II10/24/2016

Burel Pharmaceuticals Inc

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

TerminatedVoluntary: Firm initiated
Class II07/24/2020

Vilvet Pharmaceuticals Inc.

cGMP deviations

TerminatedVoluntary: Firm initiated
Class II10/24/2016

Burel Pharmaceuticals Inc

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

TerminatedVoluntary: Firm initiated
Class II10/24/2016

Burel Pharmaceuticals Inc

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is Methylene Blue used for?

Methylene Blue contains METHYLENE BLUE. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is Methylene Blue a controlled substance?

Methylene Blue is not classified as a controlled substance by the DEA.

What is the generic name for Methylene Blue?

The generic name for Methylene Blue is METHYLENE BLUE. There are 11 other brand versions of METHYLENE BLUE.

What is the NDC code for Methylene Blue 5 mg/mL?

The NDC (National Drug Code) for Methylene Blue 5 mg/mL is 15243-344, listed by OLIC (Thailand) Limited.