FDA recall D-008-2014

Product

Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.28 mL (4 fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, Florida 32773, NDC 28105-150-04.

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

2013-09-08

Report date

2013-11-27

Termination date

2014-08-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sanford, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-008-2014