Hill Dermaceuticals, Inc. recalls ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactu

Recalled April 2, 2014 · FDA recall D-1176-2014 · Hill Dermaceuticals

Hazard

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

Units

8,734 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

ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. for: Royal Pharmaceuticals NDC 68791-101-04

Manufacturer(s)

Hill Dermaceuticals, Inc.

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