Drug product
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.
D-610-2013
Product summary
- Event
- Event 65434
- Status
- Terminated
- Classification
- Class III
- Quantity
- 8,808 bottles
- Official record key
drug-enforcement:D-610-2013
Official wording
Reason: Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Code information: Lot #: H110940, Exp 08/13
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Subpotent