Drug product
ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Royal Pharmaceuticals NDC 68791-103-20
D-1178-2014
Product summary
- Event
- Event 67420
- Status
- Terminated
- Classification
- Class III
- Quantity
- 13,379 bottles
- Official record key
drug-enforcement:D-1178-2014
Official wording
Reason: Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Code information: 13F015B exp. 12/14, 13G023B exp. 01/15
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Subpotent