Status
Terminated
Drug Enforcement D-218-2013
Subpotent; 22 month stability timepoint
Classification
Class III
Report Date
April 3, 2013
Termination Date
May 28, 2013
Product Information
- Product description
- Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE, Net Contents 118.28 mL (4 fl. oz.), Hill Dermaceuticals, Inc., Sanford, Florida --- NDC 28105-149-04
- Product quantity
- 8,592 bottles
- Reason for recall
- Subpotent; 22 month stability timepoint
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide
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-218-2013
- Event ID
- 64455
- Recall initiation date
- November 21, 2012
- Center classification date
- March 22, 2013
- Code info
- Lot # D110550, Exp. 04/2013.
- More code info
- —