FDA recall D-217-2013
Hill Dermaceuticals, Inc. · Class III · drug
Product
Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill Dermaceuticals, Inc., Sanford, Florida 32773 --- NDC 28105-150-04
Reason for recall
Subpotent; 12 month stability timepoint
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2012-11-21
- Report date
- 2013-04-03
- Termination date
- 2013-05-28
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Sanford, FL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-217-2013