The Recall Desk

FDA (Drugs) recall action 69359

Valeant Pharmaceuticals International recalled 2 products on 2014-10-22

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
2014-10-22
Critical
0
Units
35,881

Why these products were recalled

Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point

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

1–2 of 2

  • ModerateFDA (Drugs)··2014-10-22

    Valeant Recalls Subpotent Hydrocortisone Butyrate Cream 0.1% Tubes

    Valeant Pharmaceuticals is recalling 34,218 tubes of Hydrocortisone Butyrate Cream 0.1% because the product failed stability testing for potency and preservative levels.

    Product
    Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufactured for: Rouses Point Pharmaceuticals, LLC Cranford, NJ 07016 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 43478-270-15
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2014-10-22

    Valeant Recalls Subpotent Locoid Hydrocortisone Butyrate Cream Tubes

    Valeant Pharmaceuticals is recalling 1,663 tubes of Locoid cream because the active ingredient and preservatives were subpotent at the 18-month stability test point.

    Product
    Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, Manufactured for: Onset Dermatologics, LLC, Cumberland, RI 02864 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 16781-382-15
    Category
    Distribution
    1 state