Drug product
Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill Dermaceuticals, Inc., Sanford, Florida 32773 --- NDC 28105-150-04
D-217-2013
Product summary
- Event
- Event 64455
- Status
- Terminated
- Classification
- Class III
- Quantity
- 8,736 bottles
- Official record key
drug-enforcement:D-217-2013
Official wording
Reason: Subpotent; 12 month stability timepoint
Code information: Lot J111040, Exp. (09/13)
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent