FDA recall D-0612-2017

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 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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-03-02

Report date

2017-03-29

Termination date

2018-07-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Melville, NY, United States

Primary source

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