FDA recall D-1177-2014

Product

ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals for: Royal Pharmaceuticals NDC 68791-102-04

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

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-1177-2014