Recalls / Class III

Class IIID-1646-2012

Product

Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottle, Rx only, FOR TOPICAL USE ONLY NOT, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-149-04

Affected lot / code info

Lot Numbers: -Scalp Oil: H100084 (exp 08/12), H100086 (08/12), J100093 (exp 08/12), J100094 (exp 09/12), J100097 (exp 09/12), K100101 (exp 09/12), K100103 (exp 10/12), K100104 (exp 10/12), K100108 (exp 10/12), K100112 (exp 10/12), L100860 (exp 11/12), L100890 (exp 11/12), L100910 (exp 11/12).

Why it was recalled

Subpotent; fluocinolone acetonide

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

161,064 bottles

Distribution pattern

Nationwide

Timeline

Recall initiated

2012-05-08

FDA classified

2012-08-14

Posted by FDA

2012-08-22

Terminated

2015-02-10

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1646-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.