Status
Terminated
Drug Enforcement D-008-2014
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Classification
Class III
Report Date
November 27, 2013
Termination Date
August 4, 2014
Product Information
- Product description
- Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.28 mL (4 fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, Florida 32773, NDC 28105-150-04.
- Product quantity
- —
- 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
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- 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-008-2014
- Event ID
- 66371
- Recall initiation date
- September 8, 2013
- Center classification date
- November 20, 2013
- Code info
- K111100 exp.10/13, K111110 exp.10/13, M111240 exp.12/13, and A120012 exp.01/14
- More code info
- —