Hill Dermaceuticals, Inc. recalls Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Scalp Oil), 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufact

Recalled November 27, 2013 · FDA recall D-007-2014 · Hill Dermaceuticals

Hazard

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. · FDA Class III

Sold at

Nationwide and Puerto Rico.

Description

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

Product

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.

Manufacturer(s)

Hill Dermaceuticals, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →