FDA (Drugs) recall action 78143
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.
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.
AbbVie is recalling 48 cartons of AndroGel testosterone gel distributed in Arizona due to prolonged exposure to temperatures outside labeled storage conditions.
AbbVie is recalling specific lots of AndroGel testosterone gel because prolonged exposure to temperatures outside labeled storage conditions may have affected the product.