Drugplain

fluocinonide .5 mg/mL

fluocinonide · SOLUTION · Bryant Ranch Prepack

10 Recalls on Record
Plain English

fluocinonide is a solution containing fluocinonide at .5 mg/mL, taken topical. Manufactured by Bryant Ranch Prepack.

Key Facts

Brand Name
fluocinonide
Generic Name
fluocinonide
NDC Code (Product)
72162-2146
Manufacturer
Bryant Ranch Prepack
Strength
.5 mg/mL
Dosage Form
SOLUTION
Route
TOPICAL
Marketing Status
Application #
ANDA072934
Drug Class
Corticosteroid [EPC]
Marketing Start
02/27/1995

Recall History

10 Recalls on Record
Class III03/17/2017

Taro Pharmaceuticals U.S.A., Inc.

Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.

TerminatedVoluntary: Firm initiated
Class II03/25/2026

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

OngoingVoluntary: Firm initiated
Class III09/20/2017

Taro Pharmaceuticals U.S.A., Inc.

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

TerminatedVoluntary: Firm initiated
Class II03/25/2026

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

OngoingVoluntary: Firm initiated
Class II03/25/2016

Reliable Rexall-A Compounding Pharmacy

Lack of Processing Controls

TerminatedVoluntary: Firm initiated
Class II03/25/2026

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

OngoingVoluntary: Firm initiated
Class III09/28/2020

Teligent Pharma, Inc.

Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.

TerminatedVoluntary: Firm initiated
Class II03/15/2022

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

TerminatedVoluntary: Firm initiated
Class II02/10/2017

Synergy Rx

Lack of Assurance of Sterility: There are also CGMP Deviations.

TerminatedVoluntary: Firm initiated
Class II03/15/2022

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective753 reports
psoriasis541 reports
rash445 reports
pruritus414 reports
diarrhoea282 reports
fatigue281 reports
nausea274 reports
pain269 reports
off label use266 reports
headache256 reports

Full Prescribing Information

Full prescribing information not available for this product.

Frequently Asked Questions

What is fluocinonide used for?

fluocinonide contains fluocinonide. It is a solution taken topical. Consult your doctor for specific uses.

Is fluocinonide a controlled substance?

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

What is the generic name for fluocinonide?

The generic name for fluocinonide is fluocinonide. There are 11 other brand versions of fluocinonide.

What is the NDC code for fluocinonide .5 mg/mL?

The NDC (National Drug Code) for fluocinonide .5 mg/mL is 72162-2146, listed by Bryant Ranch Prepack.

Product NDC

72162-2146

Package NDC

72162-2146-6

Other fluocinonide Dosages

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)