Fougera Pharmaceuticals recalls
FDA enforcement reports naming Fougera Pharmaceuticals Inc. as the recalling firm.
- Recall reports
- 8
- Class I (serious)
- 0
- Most recent report
- Mar 29, 2017
- Mar 29, 2017Desonide Ointment, 0Drug · Fougera Pharmaceuticals Inc.Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole CreamClass II
- Nov 19, 2014FLUOCINONIDE GEL USP, 0Drug · Fougera Pharmaceuticals Inc.Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.Class II
- Jul 23, 2014Triamcinolone Acetonide Lotion USP, 0Drug · Fougera Pharmaceuticals Inc.Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.Class III
- Jul 23, 2014Triamcinolone Acetonide Lotion USP, 0Drug · Fougera Pharmaceuticals Inc.Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.Class III
- Mar 19, 2014Triamcinolone Acetonide Cream USP, 0Drug · Fougera Pharmaceuticals Inc.Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.Class III
- Feb 5, 2014KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, EDrug · Fougera Pharmaceuticals Inc.Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.Class III
- Apr 10, 2013Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with EDrug · Fougera Pharmaceuticals Inc.Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant productClass III
- Aug 1, 2012Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx onlyDrug · Fougera Pharmaceuticals, Inc.Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.Class III