Drug & medication recalls Moderate risk

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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