Drug recall D-1173-2014

Class III Terminated reported Apr 2, 2014

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

Reason for recall

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

Lots and codes

12H028B exp. 01/14

Recall details

Recalling firm
Hill Dermaceuticals, Inc., Sanford, FL
Quantity
4,080 bottles
Distribution
Nationwide and Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
January 31, 2014
Terminated
February 3, 2015