PlainRecalls
FDA Drug Low Class III Terminated

Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill Dermaceuticals, Inc., Sanford, Florida 32773 --- NDC 28105-150-04

Reported: April 3, 2013 Initiated: November 21, 2012 #D-217-2013

Product Description

Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill Dermaceuticals, Inc., Sanford, Florida 32773 --- NDC 28105-150-04

Reason for Recall

Subpotent; 12 month stability timepoint

Details

Recalling Firm
Hill Dermaceuticals, Inc.
Units Affected
8,736 bottles
Distribution
Nationwide
Location
Sanford, FL

Frequently Asked Questions

What product was recalled?
Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill Dermaceuticals, Inc., Sanford, Florida 32773 --- NDC 28105-150-04. Recalled by Hill Dermaceuticals, Inc.. Units affected: 8,736 bottles.
Why was this product recalled?
Subpotent; 12 month stability timepoint
Which agency issued this recall?
This recall was issued by the FDA Drug on April 3, 2013. Severity: Low. Recall number: D-217-2013.