Drug product
Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl. oz. (118.28mL ), Rx only, FOR TOPICAL USE ONLY, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-150-04
D-1647-2012
Product summary
- Event
- Event 62607
- Status
- Terminated
- Classification
- Class III
- Quantity
- 111,816 bottles
- Official record key
drug-enforcement:D-1647-2012
Official wording
Reason: Subpotent; fluocinolone acetonide
Code information: Lot Numbers: -Body Oil: J100095 (exp 09/12), J100099 (exp 09/12), K100106 (exp 10/12), K100111 (exp 10/12), L100872 (exp 11/12), L100880 (exp 11/12), D110560 (exp 04/13).
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent