FLUOCINOLONE ACETONIDE

Generic: FLUOCINOLONE ACETONIDE

ANI PharmaceuticalsManufacturer
TOPICALRoute
FLUOCINOLONE ACETONIDEActive Substance
1963-02-15Original Approval

FLUOCINOLONE ACETONIDE is FDA application NDA012787, sponsored by EUROFARMA. 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 II2018-10-05
Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore,

Failed Impurities/Degradation Specifications:Out of specification result noticed for total impuritie

Class III2025-12-30
Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known

Class II2018-04-13
Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx Only, Manufactured by: Lyne Laboratories,

Subpotent Drug

Class II2018-04-13
Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton,

Subpotent Drug

Class II2019-01-15
Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, In

Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out o

Class III2017-02-22
Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only,

Chemical Contamination

Class II2018-04-13
Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx Only, Manufactured by: Lyne Laboratories,

Subpotent Drug

Class II2018-07-05
Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, I

Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test

Class III2013-09-30
G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60 ), Rx Only, Manuf

Failed Content Uniformity Specifications; at the 18 month time point.

Class II2024-01-04
Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Gl

Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol

Top Reported Reactions

1
DRUG INEFFECTIVE
169 reports
2
PRURITUS
155 reports
3
RASH
138 reports
4
DIARRHOEA
114 reports
5
PSORIASIS
96 reports
6
OFF LABEL USE
95 reports
7
FATIGUE
88 reports
8
HEADACHE
87 reports
9
PAIN
79 reports
10
NAUSEA
78 reports