Drug recall D-217-2013

Class III Terminated reported Apr 3, 2013

Product

Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill Dermaceuticals, Inc., Sanford, Florida 32773 --- NDC 28105-150-04

Reason for recall

Subpotent; 12 month stability timepoint

Lots and codes

Lot J111040, Exp. (09/13)

Recall details

Recalling firm
Hill Dermaceuticals, Inc., Sanford, FL
Quantity
8,736 bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
November 21, 2012
Terminated
May 28, 2013