Drug product
Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottle, Rx only, FOR TOPICAL USE ONLY NOT, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-149-04
D-1646-2012
Product summary
- Event
- Event 62607
- Status
- Terminated
- Classification
- Class III
- Quantity
- 161,064 bottles
- Official record key
drug-enforcement:D-1646-2012
Official wording
Reason: Subpotent; fluocinolone acetonide
Code information: Lot Numbers: -Scalp Oil: H100084 (exp 08/12), H100086 (08/12), J100093 (exp 08/12), J100094 (exp 09/12), J100097 (exp 09/12), K100101 (exp 09/12), K100103 (exp 10/12), K100104 (exp 10/12), K100108 (exp 10/12), K100112 (exp 10/12), L100860 (exp 11/12), L100890 (exp 11/12), L100910 (exp 11/12).
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent