Recalls / Class III

Class IIID-1647-2012

Product

Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl. oz. (118.28mL ), Rx only, FOR TOPICAL USE ONLY, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-150-04

Affected lot / code info

Lot Numbers: -Body Oil: J100095 (exp 09/12), J100099 (exp 09/12), K100106 (exp 10/12), K100111 (exp 10/12), L100872 (exp 11/12), L100880 (exp 11/12), D110560 (exp 04/13).

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

111,816 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-1647-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.