Recalls / Class III
Class IIID-217-2013
Product
Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill Dermaceuticals, Inc., Sanford, Florida 32773 --- NDC 28105-150-04
- Affected lot / code info
- Lot J111040, Exp. (09/13)
Why it was recalled
Subpotent; 12 month stability timepoint
Recalling firm
- Firm
- Hill Dermaceuticals, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 2650 S Mellonville Ave, Sanford, Florida 32773-9311
Distribution
- Quantity
- 8,736 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-11-21
- FDA classified
- 2013-03-22
- Posted by FDA
- 2013-04-03
- Terminated
- 2013-05-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-217-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.