Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill Dermaceuti...
FDA Recall #D-217-2013 — Class III — November 21, 2012
Product Description
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
Recalling Firm
Hill Dermaceuticals, Inc. — Sanford, FL
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
8,736 bottles
Distribution
Nationwide
Code Information
Lot J111040, Exp. (09/13)
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated