FDA-Drug2017-03-29Class II

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

Fougera Pharmaceuticals Inc.
Hazard

Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream

Sold states
Nationwide
Affected count
14,665 tubes
Manufactured in
60 Baylis Rd, Melville, NY, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0612-2017

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