drugs Class III Updated 2013-11-27

Hill Dermaceuticals, Inc. recalls Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil

Recalled Product

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

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: K111090 exp.10/13, K111122 exp10/13, K111140 exp.10/13, K111150 exp.10/13, 111180 exp.11/13, L111190 exp11/13, M111250 exp.12/13, M111270 exp.12/13, and M111292 exp.12/13
View official government recall

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