FDA recall D-1178-2014

Hill Dermaceuticals, Inc. · Class III · drug

Product

ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Royal Pharmaceuticals NDC 68791-103-20

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-1178-2014