FDA (Drugs) recall action 80997
The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
The agency’s own wording, quoted from the enforcement report.
Noven Pharmaceuticals is recalling Minivelle (estradiol) transdermal patches because the adhesive delivery system failed to meet specification standards for shear.
Noven Pharmaceuticals is recalling Minivelle (estradiol) transdermal patches because the adhesive delivery system failed to meet specification standards for shear.
Noven Pharmaceuticals is recalling Minivelle (estradiol) transdermal patches because the adhesive delivery system failed to meet specification standards for shear.
Noven Pharmaceuticals is recalling Minivelle (estradiol) transdermal patches because the adhesive delivery system failed to meet specification standards for shear.