Class I - Dangerous
Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream
Fougera Pharmaceuticals
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>.
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Class I - Dangerous
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 product
Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.