Status
Terminated
Drug Enforcement D-1647-2012
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%, 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
- Product quantity
- 111,816 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-1647-2012
- Event ID
- 62607
- Recall initiation date
- May 8, 2012
- Center classification date
- August 14, 2012
- Code info
- 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).
- More code info
- —