FDA Drug recall D-241-2013
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
- terminated
- Published 2013-04-10
On 2013-04-10 the FDA classified a Class III recall of Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals Inc., Melville, New… by Fougera Pharmaceuticals, citing 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 degra….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-241-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-07-18 |
| Published | 2013-04-10 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fougera Pharmaceuticals |
| Distribution | US |
Product
Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-15
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
Identifiers
| ndc | 0168-0099-15 |
|---|---|
| ndc | 0168-0099-30 |
| ndc | 0168-0099-60 |
| code_info | Lot #: 835H, Exp 07/12 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Fougera Pharmaceuticals
- 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 - 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 - 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 - 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 - 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
All Fougera Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-241-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.