FLUCONAZOLE

Generic: FLUCONAZOLE

Rising Pharma HoldingsManufacturer
ORALRoute
FLUCONAZOLEActive Substance
2008-10-07Original Approval

FLUCONAZOLE is FDA application ANDA077731, sponsored by AUROBINDO PHARMA. 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 II2016-12-28
Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 Ind

Failed Dissolution Specifications; 18 month stability time point

Class II2016-12-28
Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 55111-143-01) bottles, Rx Only, Mf

Failed Dissolution Specifications; 18 month stability time point

Class II2014-12-23
Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL

Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.

Class II2016-12-28
Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC 55111-144-01) bottles, Rx Only, M

Failed Dissolution Specifications; 18 month stability time point

Class II2017-01-05
Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited,

Failed Dissolution Specifications

Class II2017-01-05
Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited,

Failed Dissolution Specifications

Class II2017-05-15
Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcar

Lack of assurance of sterility: customer complaints received for the presence of leaks.

Class II2016-12-06
Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcar

Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.

Class II2014-01-29
GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted, Rx only, Distributed by

Defective Container: Tamper evident ring failures discovered on some bottles.

Class II2016-12-28
Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, M

Failed Dissolution Specifications; 18 month stability time point

Top Reported Reactions

1
DRUG INEFFECTIVE
4,587 reports
2
OFF LABEL USE
4,043 reports
3
PYREXIA
3,344 reports
4
NAUSEA
2,869 reports
5
DIARRHOEA
2,786 reports
6
DRUG INTERACTION
2,713 reports
7
FATIGUE
2,505 reports
8
PAIN
2,386 reports
9
HEADACHE
2,321 reports
10
FEBRILE NEUTROPENIA
2,291 reports