FLUOCINONIDE

Generic: FLUOCINONIDE

Padagis Israel Pharmaceuticals LtdManufacturer
TOPICALRoute
FLUOCINONIDEActive Substance
2018-06-19Original Approval

FLUOCINONIDE is FDA application ANDA209030, sponsored by PADAGIS US. 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 III2017-03-17
Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Bra

Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contami

Class II2026-03-25
Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1,

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in vi

Class III2017-09-20
Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton Ontario Canada L6T1C1, Dis

Cross contamination with other products: traces of Dapsone were found in the finished product.

Class II2026-03-25
Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1,

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in vi

Class II2026-03-25
Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1,

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in vi

Top Reported Reactions

1
DRUG INEFFECTIVE
763 reports
2
PSORIASIS
545 reports
3
RASH
454 reports
4
PRURITUS
426 reports
5
FATIGUE
288 reports
6
DIARRHOEA
285 reports
7
NAUSEA
275 reports
8
PAIN
273 reports
9
OFF LABEL USE
272 reports
10
HEADACHE
262 reports