FDA (Drugs) recall action 62530
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.
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
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 231,270 Daytrana patches because the release liner may be difficult to remove.
Noven Pharmaceuticals is recalling 177,900 Daytrana (methylphenidate) patches because the delivery system may be miscalibrated or defective, potentially affecting the removal of the release liner.
Noven Pharmaceuticals is recalling 121,530 Daytrana patches because the release liner may be difficult to remove. The defect affects the patch's mechanical peel force.