D-610-2013 Class III Terminated
FDA drug recall D-610-2013 was initiated by Hill Dermaceuticals, Inc. on May 7, 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 July 19, 2013). Affected quantity: 8,808 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 3, 2013
- Initiation Date
- May 7, 2013
- Termination Date
- July 19, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,808 bottles
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.
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
Lot #: H110940, Exp 08/13