Drug product
Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. oz., Rx only. Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-149-04
D-1174-2014
Product summary
- Event
- Event 67420
- Status
- Terminated
- Classification
- Class III
- Quantity
- 14,226 bottles
- Official record key
drug-enforcement:D-1174-2014
Official wording
Reason: Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Code information: 12J030C exp. 03/14, 12L041C exp. 05/14
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Subpotent