FDAFDA · Food and drugs·Recall number D-610-2013
Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA 32773; NDC 28105-149-04.
Published July 3, 2013 · Recall initiated: May 7, 2013
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 · Letter
Recall details
- Manufacturer
- Hill Dermaceuticals, Inc.
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot #: H110940, Exp 08/13
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.