The Recall Desk

FDA (Drugs) recall action 78143

AbbVie Inc. recalled 2 products on 2017-11-01

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
2017-11-01
Critical
0
Units
520

Why these products were recalled

Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.

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

  • LowFDA (Drugs)··2017-11-01

    AbbVie Recalls AndroGel Testosterone Gel Due to Temperature Abuse

    AbbVie is recalling specific lots of AndroGel testosterone gel because prolonged exposure to temperatures outside labeled storage conditions may have affected the product.

    Product
    AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuation, 60 metered pump actuations, Rx Only, Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-33
    Category
    Distribution
    1 state
  • LowFDA (Drugs)··2017-11-01

    AbbVie Recalls AndroGel Testosterone Gel Due to Temperature Abuse

    AbbVie is recalling 48 cartons of AndroGel testosterone gel distributed in Arizona due to prolonged exposure to temperatures outside labeled storage conditions.

    Product
    AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Packets per carton. Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-30
    Category
    Distribution
    1 state