Drug product
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.
D-008-2014
Product summary
- Event
- Event 66371
- Status
- Terminated
- Classification
- Class III
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-008-2014
Official wording
Reason: Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Code information: K111100 exp.10/13, K111110 exp.10/13, M111240 exp.12/13, and A120012 exp.01/14
Distribution pattern: Nationwide and Puerto Rico.
Derived failure modes
-
Potency or specification failure
Subpotent