Drugplain

VITRAKVI 20 mg/mL

LAROTRECTINIB · SOLUTION, CONCENTRATE · Bayer HealthCare Pharmaceuticals Inc.

1 Recall on Record
Plain English

VITRAKVI is a solution, concentrate containing larotrectinib at 20 mg/mL, taken oropharyngeal. Manufactured by Bayer HealthCare Pharmaceuticals Inc..

Key Facts

Brand Name
VITRAKVI
Generic Name
LAROTRECTINIB
NDC Code (Product)
50419-392
Manufacturer
Bayer HealthCare Pharmaceuticals Inc.
Strength
20 mg/mL
Dosage Form
SOLUTION, CONCENTRATE
Route
OROPHARYNGEAL
Marketing Status
Application #
NDA211710
Drug Class
Kinase Inhibitor [EPC]
Marketing Start
07/26/2019

Recall History

1 Recall on Record
Class I11/06/2023

Bayer Healthcare Pharmaceuticals Inc.

Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is VITRAKVI used for?

VITRAKVI contains LAROTRECTINIB. It is a solution, concentrate taken oropharyngeal. Consult your doctor for specific uses.

Is VITRAKVI a controlled substance?

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

What is the generic name for VITRAKVI?

The generic name for VITRAKVI is LAROTRECTINIB. There are no other listed brand versions of LAROTRECTINIB.

What is the NDC code for VITRAKVI 20 mg/mL?

The NDC (National Drug Code) for VITRAKVI 20 mg/mL is 50419-392, listed by Bayer HealthCare Pharmaceuticals Inc..

Product NDC

50419-392

Package NDC

50419-392-01

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)