Recalls / Class III
Class IIID-610-2013
Product
Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA 32773; NDC 28105-149-04.
- Affected lot / code info
- Lot #: H110940, Exp 08/13
Why it was recalled
Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Recalling firm
- Firm
- Hill Dermaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2650 S Mellonville Ave, Sanford, Florida 32773-9311
Distribution
- Quantity
- 8,808 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-05-07
- FDA classified
- 2013-06-21
- Posted by FDA
- 2013-07-03
- Terminated
- 2013-07-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-610-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.