Fougera Pharmaceuticals, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 0
- Inspections
- 25
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0612-2017 | Class II | Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Ph | March 2, 2017 |
| D-0245-2015 | Class II | FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gr | August 28, 2014 |
| D-1441-2014 | Class III | Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not fo | July 3, 2014 |
| D-1440-2014 | Class III | Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for | July 3, 2014 |
| D-1152-2014 | Class III | Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A divi | January 29, 2014 |
| D-1044-2014 | Class III | KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceutica | November 18, 2013 |
| D-241-2013 | Class III | Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fouge | July 18, 2012 |
| D-1426-2012 | Class III | Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only. E. FOUGERA & CO., A di | June 7, 2012 |