FDA recall D-610-2013

Product

Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA 32773; NDC 28105-149-04.

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

2013-05-07

Report date

2013-07-03

Termination date

2013-07-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sanford, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-610-2013