FDA recall D-1647-2012

Hill Dermaceuticals, Inc. · Class III · drug

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

Reason for recall

Subpotent; fluocinolone acetonide

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2012-05-08
Report date: 2012-08-22
Termination date: 2015-02-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Sanford, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1647-2012