CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE

Generic: CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE

E. Fougera & Co. a division of Fougera PharmaceuticalsManufacturer
TOPICALRoute
CLOTRIMAZOLEActive Substance
2001-06-05Original Approval

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE is FDA application ANDA075502, sponsored by FOUGERA PHARMS. 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 II2020-11-17
CVS Health Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 1 OZ (28.4 g) Distributed by: CVS Pharma

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly

Class III2019-08-07
Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, 15 gram tubes, Rx only, Manufactured by: Glenmark Pharm

Temperature Abuse: Complaints received of liquidy texture.

Class II2025-10-31
Globe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g), Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Ave

cGMP deviations

Class II2020-11-17
Equate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream, Packaged as a) NET WT. 0.5 oz (14.2g), NDC 49035-812-01, b

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly

Class III2022-02-25
Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceutica

Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropio

Class II2025-10-31
Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Distributed by: Trifecta Pharmaceuticals USA,

cGMP deviations

Top Reported Reactions

1
DRUG INEFFECTIVE
1,410 reports
2
NAUSEA
851 reports
3
MACULAR DEGENERATION
813 reports
4
PAIN
811 reports
5
OFF LABEL USE
771 reports
6
HEADACHE
759 reports
7
DYSPNOEA
733 reports
8
FATIGUE
695 reports
9
DIARRHOEA
626 reports
10
PYREXIA
546 reports