FDA Drug recall D-1044-2014
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
- terminated
- Published 2014-02-05
On 2014-02-05 the FDA classified a Class III recall of KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC… by Fougera Pharmaceuticals, citing failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1044-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-11-18 |
| Published | 2014-02-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fougera Pharmaceuticals |
| Distribution | US |
Product
KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-30, UPC 3 0168-0099-30 9.
Reason
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Identifiers
| upc | 301680099309 |
|---|---|
| ndc | 0168-0099-15 |
| ndc | 0168-0099-30 |
| ndc | 0168-0099-60 |
| code_info | Lot #: 495P, Exp 07/14 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1044-2014%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.