Status
Terminated
Drug Enforcement D-610-2013
Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Classification
Class III
Report Date
July 3, 2013
Termination Date
July 19, 2013
Product Information
- Product description
- 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.
- Product quantity
- 8,808 bottles
- Reason for recall
- Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
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-610-2013
- Event ID
- 65434
- Recall initiation date
- May 7, 2013
- Center classification date
- June 21, 2013
- Code info
- Lot #: H110940, Exp 08/13
- More code info
- —