Fougera Pharmaceuticals Inc. recalls Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc.,…
- Recall date
- March 2, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0612-2017
- FDA classification
- Class II
- Brand / firm
- Fougera Pharmaceuticals Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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
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