Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ...
FDA Recall #D-218-2013 — Class III — November 21, 2012
Product Description
Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE, Net Contents 118.28 mL (4 fl. oz.), Hill Dermaceuticals, Inc., Sanford, Florida --- NDC 28105-149-04
Reason for Recall
Subpotent; 22 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
8,592 bottles
Distribution
Nationwide
Code Information
Lot # D110550, Exp. 04/2013.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated