FDAClass IIMarch 29, 2017

Desonide Ointment recall: Labeling Error

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…

Why was Desonide Ointment recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot GC9231 (exp. 05/2019); Lot GC9232 (exp. 05/2019)

Product
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…
Recalling firm
Fougera Pharmaceuticals Inc.
Quantity
14,665 tubes
Distribution
Nationwide
Recall date
March 29, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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