Hill Dermaceuticals, Inc. recalls DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Manufactured and Distributed by: Hill Derm
Recalled April 2, 2014 · FDA recall D-1173-2014 · 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
4,080 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
DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-160-20
Manufacturer(s)
Hill Dermaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →