D-0612-2017 Class II Terminated
FDA drug recall D-0612-2017 was initiated by Fougera Pharmaceuticals Inc. on March 2, 2017 and is designated Class II. Reason for recall: Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream The recall status is terminated (terminated July 2, 2018). Affected quantity: 14,665 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- March 29, 2017
- Initiation Date
- March 2, 2017
- Termination Date
- July 2, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,665 tubes
Product Description
Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0309-60
Reason for Recall
Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream
Distribution Pattern
Nationwide
Code Information
Lot GC9231 (exp. 05/2019); Lot GC9232 (exp. 05/2019)