FDA recall D-1173-2014

Hill Dermaceuticals, Inc. · Class III · drug

Product

DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-160-20

Reason for recall

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2014-01-31
Report date: 2014-04-02
Termination date: 2015-02-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Sanford, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1173-2014