Product Detail

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.

Recall Number D-610-2013

Classification Class III

Code Info Lot #: H110940, Exp 08/13

Product Distributed Qty 8,808 bottles

Reason For Recall Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

Event Detail

Event Id 65434

Product Type Drugs

Status Ongoing

Recalling Firm
Hill Dermaceuticals, Inc.
City Sanford

State FL
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-05-07

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Nationwide and Puerto Rico