Recalls / Class III

Class IIID-218-2013

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

Affected lot / code info

Lot # D110550, Exp. 04/2013.

Why it was recalled

Subpotent; 22 month stability timepoint

Recalling firm

Firm

Hill Dermaceuticals, Inc.

Notification channel

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Type

Voluntary: Firm initiated

Address

2650 S Mellonville Ave, Sanford, Florida 32773-9311

Distribution

Quantity

8,592 bottles

Distribution pattern

Nationwide

Timeline

Recall initiated

2012-11-21

FDA classified

2013-03-22

Posted by FDA

2013-04-03

Terminated

2013-05-28

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-218-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.