Drug product
SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-508-20
D-1181-2014
Product summary
- Event
- Event 67420
- Status
- Terminated
- Classification
- Class III
- Quantity
- 13,591 bottles
- Official record key
drug-enforcement:D-1181-2014
Official wording
Reason: Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Code information: 13F017B exp. 12/14, 13F020B exp 12/14
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Subpotent