FDAFDA · Food and drugs·Recall number D-008-2014
Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.28 mL (4 fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, Florida 32773, NDC 28105-150-04.
Published November 27, 2013 · Recall initiated: September 8, 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 · 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
- K111100 exp.10/13, K111110 exp.10/13, M111240 exp.12/13, and A120012 exp.01/14
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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