The Recall Desk

FDA (Drugs) recall action 74623

Allergan Sales, LLC recalled 2 products on 2016-10-19

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
2016-10-19
Critical
0
Units
17,112

Why these products were recalled

Failed Content Uniformity Specifications

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

  • SevereFDA (Drugs)··2016-10-19

    Allergan Recalls Tazorac Gel 0.05% Due to Content Uniformity Failures

    Allergan Sales, LLC is recalling 17,112 tubes of Tazorac (tazarotene) Gel 0.05% because the product failed content uniformity specifications.

    Product
    TAZORAC (tazarotene) Gel 0.05%, Rx only, packaged in 15 x 3.5 g professional sample containers, Manufactured by: Allergan Inc., Irvine, CA 92512. UPC: 300238335159.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-10-19

    Allergan Recalls Tazorac Gel 0.05% Due to Content Uniformity Failures

    Allergan Sales, LLC is recalling Tazorac (tazarotene) Gel 0.05% because it failed content uniformity specifications. The recall covers 25,247 tubes distributed nationwide.

    Product
    TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for Ophthalmic Use, packaged in a) 30 g tubes (NDC: 0023-8335-03, UPC: 300238335036) and b)100 g tubes,(NDC: 0023-8335-10, UPC: 300238335104), Manufactured by: Allergan Inc., Irvine, CA 92512.
    Category
    Distribution
    0 states