FDA (Drugs) recall action 88342
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.
Failed Stability Specifications; out of specification for shear.
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.
Noven Pharmaceuticals is recalling Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day because certain lots failed stability specifications and tested out of specification for shear.
Noven Pharmaceuticals is recalling certain lots of Combipatch (estradiol/norethindrone acetate transdermal system) distributed nationwide because the patches failed stability testing and fell out of specification for shear properties.