VORICONAZOLE

Generic: VORICONAZOLE

Mylan Pharmaceuticals Inc.Manufacturer

ORALRoute

VORICONAZOLEActive Substance

2010-04-22Original Approval

VORICONAZOLE is FDA application ANDA090547, sponsored by MYLAN PHARMS INC. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2025-03-13

Voriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhy

CGMP Deviations

Class II2025-03-24

Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose per

cGMP Deviations: Received notification from their supplier requesting they perform a recall due to t

Class II2024-02-05

Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bott

Labeling: Incorrect or Missing Package Insert

Class II2025-03-13

Voriconazole Tablets 200 mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Mad

CGMP Deviations

Top Reported Reactions

1

DRUG INEFFECTIVE

3,938 reports

2

OFF LABEL USE

2,077 reports

3

DRUG INTERACTION

2,013 reports

4

PYREXIA

1,060 reports

5

PNEUMONIA

903 reports

6

BRONCHOPULMONARY ASPERGILLOSIS

882 reports

7

CONDITION AGGRAVATED

855 reports

8

ASPERGILLUS INFECTION

831 reports

9

FEBRILE NEUTROPENIA

737 reports

10

DEATH

722 reports