Drug recall D-218-2013

Class III Terminated reported Apr 3, 2013

Product

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

Lots and codes

Lot # D110550, Exp. 04/2013.

Recall details

Recalling firm
Hill Dermaceuticals, Inc., Sanford, FL
Quantity
8,592 bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
November 21, 2012
Terminated
May 28, 2013