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
Reported: March 29, 2017 Initiated: March 2, 2017 #D-0612-2017
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
Details
- Recalling Firm
- Fougera Pharmaceuticals Inc.
- Units Affected
- 14,665 tubes
- Distribution
- Nationwide
- Location
- Melville, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Fougera Pharmaceuticals Inc.. Units affected: 14,665 tubes.
Why was this product recalled? ▼
Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 29, 2017. Severity: Moderate. Recall number: D-0612-2017.
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