Status
Terminated
Drug Enforcement D-217-2013
Subpotent; 12 month stability timepoint
Classification
Class III
Report Date
April 3, 2013
Termination Date
May 28, 2013
Product Information
- Product description
- Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill Dermaceuticals, Inc., Sanford, Florida 32773 --- NDC 28105-150-04
- Product quantity
- 8,736 bottles
- Reason for recall
- Subpotent; 12 month stability timepoint
- 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-217-2013
- Event ID
- 64455
- Recall initiation date
- November 21, 2012
- Center classification date
- March 22, 2013
- Code info
- Lot J111040, Exp. (09/13)
- More code info
- —