The Recall Desk

FDA (Drugs) recall action 67420

Hill Dermaceuticals, Inc. recalled 9 products on 2014-04-02

The FDA (Drugs) publishes a recall like this one as 9 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 9 pages.

Products
9
Announced
2014-04-02
Critical
0
Units
81,854

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.

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.

States named across these recalls

1–9 of 9

  • ModerateFDA (Drugs)··2014-04-02

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil

    Hill Dermaceuticals is recalling 4,142 bottles of Fluocinolone acetonide 0.01% Topical Oil because the active ingredient was found to be subpotent during routine testing.

    Product
    SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-507-04
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2014-04-02

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil

    Hill Dermaceuticals is recalling 8,734 bottles of Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil because the active ingredient was found to be subpotent during routine testing.

    Product
    Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-150-04
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2014-04-02

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Ear Drops

    Hill Dermaceuticals is recalling 13,591 bottles of Fluocinolone Acetonide 0.01% Oil Ear Drops because routine testing found the active ingredient to be subpotent.

    Product
    SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-508-20
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2014-04-02

    Hill Dermaceuticals Recalls Subpotent Dermotic Ear Drops

    Hill Dermaceuticals is recalling Dermotic ear drops because the active ingredient was found to be subpotent during routine testing.

    Product
    DERMOTIC (FLUOCINOLONE ACETONIDE)
    Category
    Distribution
    1 state
  • LowFDA (Drugs)··2014-04-02

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil

    Hill Dermaceuticals is recalling 14,226 bottles of Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil because the active ingredient was found to be subpotent during routine testing.

    Product
    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
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2014-04-02

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil

    Hill Dermaceuticals is recalling 7,676 bottles of Fluocinolone Acetonide 0.01% Topical Oil because the active ingredient was found to be subpotent during routine testing.

    Product
    SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-506-04
    Category
    Distribution
    1 state
  • LowFDA (Drugs)··2014-04-02

    Hill Dermaceuticals Recalls Subpotent DermOtic Oil Ear Drops

    Hill Dermaceuticals is recalling DermOtic Oil ear drops because the active ingredient was found to be subpotent during routine testing.

    Product
    DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-160-20
    Category
    Distribution
    1 state