Hill Dermaceuticals, Inc. recalls ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Derm
Recalled April 2, 2014 · FDA recall D-1178-2014 · 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
13,379 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 DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Royal Pharmaceuticals NDC 68791-103-20
Manufacturer(s)
Hill Dermaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →