FDA (Drugs) recall action 66838
The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
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.
Forest Pharmaceuticals is recalling 156 bottles of Namenda XR 7 mg capsules because they failed stability dissolution testing. The affected product was distributed nationwide and in Puerto Rico.
Forest Pharmaceuticals is recalling Namenda XR sample packs because they failed stability dissolution testing. The affected lots were distributed nationwide and in Puerto Rico.
Forest Pharmaceuticals is recalling 3,950 packs of Namenda XR titration packs because they failed stability dissolution testing.