The Recall Desk

FDA (Drugs) recall action 66371

Hill Dermaceuticals, Inc. recalled 2 products on 2013-11-27

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-11-27
Critical
0
Units
—

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • LowFDA (Drugs)··2013-11-27

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil

    Hill Dermaceuticals is recalling Derma-Smoothe/FS topical oil because routine testing found the active ingredient to be subpotent.

    Product
    Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.28 mL (4 fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, Florida 32773, NDC 28105-150-04.
    Category
    Distribution
    1 state
  • LowFDA (Drugs)··2013-11-27

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil

    Hill Dermaceuticals is recalling specific lots of Derma-Smoothe/FS topical oil because routine testing found the active ingredient to be subpotent.

    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.
    Category
    Distribution
    1 state