Drug product
SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-506-04
D-1180-2014
Product summary
- Event
- Event 67420
- Status
- Terminated
- Classification
- Class III
- Quantity
- 7,676 bottles
- Official record key
drug-enforcement:D-1180-2014
Official wording
Reason: Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Code information: 13F016A exp. 12/14.
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Subpotent