D-007-2014 Class III Terminated
FDA drug recall D-007-2014 was initiated by Hill Dermaceuticals, Inc. on September 8, 2013 and is designated Class III. Reason for recall: Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. The recall status is terminated (terminated August 4, 2014).
Recall Details
- Product Type
- Drugs
- Report Date
- November 27, 2013
- Initiation Date
- September 8, 2013
- Termination Date
- August 4, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Scalp Oil), 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, Florida 32773, NDC 28105-149-04.
Reason for Recall
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Distribution Pattern
Nationwide and Puerto Rico.
Code Information
K111090 exp.10/13, K111122 exp10/13, K111140 exp.10/13, K111150 exp.10/13, 111180 exp.11/13, L111190 exp11/13, M111250 exp.12/13, M111270 exp.12/13, and M111292 exp.12/13