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

Recalled July 3, 2013 · FDA recall D-610-2013 · Hill Dermaceuticals

Hazard

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

Units

8,808 bottles

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) 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.

Manufacturer(s)

Hill Dermaceuticals, Inc.

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