Drugplain

voriconazole 50 mg/1

voriconazole · TABLET, FILM COATED · Sandoz Inc

10 Recalls on Record
Plain English

voriconazole is a tablet, film coated containing voriconazole at 50 mg/1, taken oral. Manufactured by Sandoz Inc.

Key Facts

Brand Name
voriconazole
Generic Name
voriconazole
NDC Code (Product)
0781-5667
Manufacturer
Sandoz Inc
Strength
50 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA200265
Drug Class
Azole Antifungal [EPC]
Marketing Start
12/12/2011

Recall History

10 Recalls on Record
Class II08/27/2014

Martin Avenue Pharmacy, Inc.

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

TerminatedVoluntary: Firm initiated
Class II12/22/2022

Pharmacy Innovations

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

TerminatedVoluntary: Firm initiated
Class II05/21/2012

Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

TerminatedVoluntary: Firm initiated
Class II09/12/2015

US Compounding Inc

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

TerminatedVoluntary: Firm initiated
Class II03/13/2025

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations

OngoingVoluntary: Firm initiated
Class II11/01/2013

Natures Pharmacy & Compounding Center

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

TerminatedVoluntary: Firm initiated
Class II10/07/2022

Pharmacy Plus, Inc. dba Vital Care Compounder

Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

OngoingVoluntary: 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 II11/01/2013

Natures Pharmacy & Compounding Center

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

TerminatedVoluntary: Firm initiated
Class II03/24/2025

Amerisource Health Services LLC

cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is voriconazole used for?

voriconazole contains voriconazole. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is voriconazole a controlled substance?

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

What is the generic name for voriconazole?

The generic name for voriconazole is voriconazole. There are 9 other brand versions of voriconazole.

What is the NDC code for voriconazole 50 mg/1?

The NDC (National Drug Code) for voriconazole 50 mg/1 is 0781-5667, listed by Sandoz Inc.