FDA recall D-218-2013

Hill Dermaceuticals, Inc. · Class III · drug

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

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2012-11-21
Report date: 2013-04-03
Termination date: 2013-05-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Sanford, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-218-2013