The Recall Desk

FDA (Drugs) recall action 64455

Hill Dermaceuticals, Inc. recalled 2 products on 2013-04-03

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
2013-04-03
Critical
0
Units
17,328

Why these products were recalled

Subpotent; 12 month stability timepoint

Subpotent; 22 month stability timepoint

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

  • LowFDA (Drugs)··2013-04-03

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil

    Hill Dermaceuticals is recalling 8,736 bottles of Derma-Smoothe/FS topical oil because the product was found to be subpotent at the 12-month stability timepoint.

    Product
    Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill Dermaceuticals, Inc., Sanford, Florida 32773 --- NDC 28105-150-04
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2013-04-03

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil

    Hill Dermaceuticals is recalling 8,592 bottles of Derma-Smoothe/FS topical oil because the product was found to be subpotent at a 22-month stability timepoint.

    Product
    Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE, Net Contents 118.28 mL (4 fl. oz.), Hill Dermaceuticals, Inc., Sanford, Florida --- NDC 28105-149-04
    Category
    Distribution
    0 states