FDAFDA · Food and drugs·Recall number D-1174-2014
Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. oz., Rx only. Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-149-04
Published April 2, 2014 · Recall initiated: January 31, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Hill Dermaceuticals, Inc.
- Distributor
- Nationwide and Puerto Rico
- Lot
- 12J030C exp. 03/14, 12L041C exp. 05/14
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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