Product: Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Scalp Oil), 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, Florida 32773, NDC 28105-149-04.
Reason for recall: Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Recall initiated: 20130908
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated