Drug product
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals for: Royal Pharmaceuticals NDC 68791-102-04
D-1177-2014
Product summary
- Event
- Event 67420
- Status
- Terminated
- Classification
- Class III
- Quantity
- 7,292 bottles
- Official record key
drug-enforcement:D-1177-2014
Official wording
Reason: Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Code information: 13E014A exp. 11/14, 13F02C exp 12/14.
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Subpotent