FDA-Drug2014-04-02Class III

Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. oz., Rx only. Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-149-04

Hill Dermaceuticals, Inc.
Hazard

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

Sold states
Nationwide and Puerto Rico
Affected count
14,226 bottles
Manufactured in
2650 S Mellonville Ave, N/A, Sanford, FL, United States
Products
Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. oz., Rx only. Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-149-04

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1174-2014

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