PlainRecalls
FDA Drug Low Class III Terminated

Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottle, Rx only, FOR TOPICAL USE ONLY NOT, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-149-04

Reported: August 22, 2012 Initiated: May 8, 2012 #D-1646-2012

Product Description

Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottle, Rx only, FOR TOPICAL USE ONLY NOT, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-149-04

Reason for Recall

Subpotent; fluocinolone acetonide

Details

Recalling Firm
Hill Dermaceuticals, Inc.
Units Affected
161,064 bottles
Distribution
Nationwide
Location
Sanford, FL

Frequently Asked Questions

What product was recalled?
Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottle, Rx only, FOR TOPICAL USE ONLY NOT, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-149-04. Recalled by Hill Dermaceuticals, Inc.. Units affected: 161,064 bottles.
Why was this product recalled?
Subpotent; fluocinolone acetonide
Which agency issued this recall?
This recall was issued by the FDA Drug on August 22, 2012. Severity: Low. Recall number: D-1646-2012.