Drug product
Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE, Net Contents 118.28 mL (4 fl. oz.), Hill Dermaceuticals, Inc., Sanford, Florida --- NDC 28105-149-04
D-218-2013
Product summary
- Event
- Event 64455
- Status
- Terminated
- Classification
- Class III
- Quantity
- 8,592 bottles
- Official record key
drug-enforcement:D-218-2013
Official wording
Reason: Subpotent; 22 month stability timepoint
Code information: Lot # D110550, Exp. 04/2013.
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent