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Fougera Pharmaceuticals Recalls
8 recalls on record · August 1, 2012 to March 29, 2017 · Drugs
Recalls by year
12
13
14
17
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 29, 2017DrugsFDA
Fougera Pharmaceuticals Inc. recalls Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc.,
Hazard: Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream
November 19, 2014DrugsFDA
Fougera Pharmaceuticals Inc. recalls FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET
Hazard: 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>.
July 23, 2014DrugsFDA
Fougera Pharmaceuticals Inc. recalls Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E.
Hazard: Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
July 23, 2014DrugsFDA
Fougera Pharmaceuticals Inc. recalls Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. F
Hazard: Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
March 19, 2014DrugsFDA
Fougera Pharmaceuticals Inc. recalls Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Phar
Hazard: Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
February 5, 2014DrugsFDA
Fougera Pharmaceuticals Inc. recalls KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, N
Hazard: Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
April 10, 2013DrugsFDA
Fougera Pharmaceuticals Inc. recalls Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals I
Hazard: 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
August 1, 2012DrugsFDA
Fougera Pharmaceuticals, Inc. recalls Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only. E. FOUGERA & CO., A division of Fougera Ph
Hazard: Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.