Status
Terminated
Drug Enforcement D-1646-2012
Subpotent; fluocinolone acetonide
Classification
Class III
Report Date
August 22, 2012
Termination Date
February 10, 2015
Product Information
- Product description
- 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
- Product quantity
- 161,064 bottles
- Reason for recall
- Subpotent; fluocinolone acetonide
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Hill Dermaceuticals, Inc.
- Address
-
2650 S Mellonville Ave
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1646-2012
- Event ID
- 62607
- Recall initiation date
- May 8, 2012
- Center classification date
- August 14, 2012
- Code info
- 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).
- More code info
- —