Fougera Pharmaceuticals recalls
Fougera Pharmaceuticals appears in 8 official U.S. recall notices indexed by RecallRadar, most recently on 2017-03-29.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 8 |
|---|---|
| Published | 2012-08-01 to 2017-03-29 |
| By agency | FDA Drug (8) |
| By classification | Class III (6), Class II (2) |
| By status | terminated (8) |
| Distribution named in notices | US |
Recalls
- Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc., Melville, New York 1…
FDA Drug · Class II · 2017-03-29 · Fougera Pharmaceuticals
Reason: Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream - FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes,…
FDA Drug · Class II · 2014-11-19 · Fougera Pharmaceuticals
Reason: 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>. - Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Divi…
FDA Drug · Class III · 2014-07-23 · Fougera Pharmaceuticals
Reason: Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry. - Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Di…
FDA Drug · Class III · 2014-07-23 · Fougera Pharmaceuticals
Reason: Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry. - Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., M…
FDA Drug · Class III · 2014-03-19 · Fougera Pharmaceuticals
Reason: Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%. - KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC…
FDA Drug · Class III · 2014-02-05 · Fougera Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications: Out-of-Specification degradant results. - Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals Inc., Melville, New…
FDA Drug · Class III · 2013-04-10 · Fougera Pharmaceuticals
Reason: 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 - Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only
FDA Drug · Class III · 2012-08-01 · Fougera Pharmaceuticals
Reason: Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.