The Recall Desk

FDA (Drugs) recall action 62607

Hill Dermaceuticals, Inc. recalled 2 products on 2012-08-22

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
2012-08-22
Critical
0
Units
272,880

Why these products were recalled

Subpotent; fluocinolone acetonide

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Drugs)··2012-08-22

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Scalp Oil

    Hill Dermaceuticals is recalling 161,064 bottles of Derma-Smoothe/FS scalp oil because the product is subpotent, meaning it contains less of the active ingredient than labeled.

    Product
    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
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2012-08-22

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Body Oil

    Hill Dermaceuticals is recalling 111,816 bottles of Derma-Smoothe/FS Body Oil because the product is subpotent, meaning it contains less of the active ingredient than labeled.

    Product
    Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl. oz. (118.28mL ), Rx only, FOR TOPICAL USE ONLY, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-150-04
    Category
    Distribution
    0 states