Drugplain

Clotrimazole 1 g/mL

Clotrimazole · SOLUTION · Granules USA, Inc.

10 Recalls on Record
Plain English

Clotrimazole is a solution containing clotrimazole at 1 g/mL, taken topical. Manufactured by Granules USA, Inc..

Key Facts

Brand Name
Clotrimazole
Generic Name
Clotrimazole
NDC Code (Product)
69848-001
Manufacturer
Granules USA, Inc.
Strength
1 g/mL
Dosage Form
SOLUTION
Route
TOPICAL
Marketing Status
Application #
M005
Drug Class
Azole Antifungal [EPC]
Marketing Start
07/01/2018

Recall History

10 Recalls on Record
Class II11/17/2020

Taro Pharmaceuticals U.S.A., Inc.

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

TerminatedVoluntary: Firm initiated
Class II11/17/2020

Taro Pharmaceuticals U.S.A., Inc.

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

TerminatedVoluntary: Firm initiated
Class II11/17/2020

Taro Pharmaceuticals U.S.A., Inc.

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

TerminatedVoluntary: Firm initiated
Class II11/17/2020

Taro Pharmaceuticals U.S.A., Inc.

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

TerminatedVoluntary: Firm initiated
Class II11/17/2020

Taro Pharmaceuticals U.S.A., Inc.

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

TerminatedVoluntary: Firm initiated
Class II05/17/2016

Well Care Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

TerminatedVoluntary: Firm initiated
Class II06/02/2015

The Compounding Pharmacy of America

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

TerminatedVoluntary: Firm initiated
Class II01/27/2017

Cherry Hill Sales Co.

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II11/17/2020

Taro Pharmaceuticals U.S.A., Inc.

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

TerminatedVoluntary: Firm initiated
Class III08/07/2019

Glenmark Pharmaceuticals Inc., USA

Temperature Abuse: Complaints received of liquidy texture.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective1,377 reports
nausea835 reports
macular degeneration804 reports
pain798 reports
off label use745 reports
headache737 reports
dyspnoea718 reports
fatigue674 reports
diarrhoea608 reports
pyrexia539 reports

Frequently Asked Questions

What is Clotrimazole used for?

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

Is Clotrimazole a controlled substance?

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

What is the generic name for Clotrimazole?

The generic name for Clotrimazole is Clotrimazole. There are 9 other brand versions of Clotrimazole.

What is the NDC code for Clotrimazole 1 g/mL?

The NDC (National Drug Code) for Clotrimazole 1 g/mL is 69848-001, listed by Granules USA, Inc..