Drug recall D-1181-2014

Class III Terminated reported Apr 2, 2014

Product

SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-508-20

Reason for recall

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

Lots and codes

13F017B exp. 12/14, 13F020B exp 12/14

Recall details

Recalling firm
Hill Dermaceuticals, Inc., Sanford, FL
Quantity
13,591 bottles
Distribution
Nationwide and Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
January 31, 2014
Terminated
February 3, 2015