FDA (Drugs) recall action 73718
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.
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver 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 2,088 boxes of Daytrana transdermal patches because the release liner may be difficult to remove.
Noven Pharmaceuticals is recalling 7,850 boxes of Daytrana (methylphenidate) transdermal patches because the release liner may be difficult to remove.
Noven Pharmaceuticals is recalling specific lots of Daytrana transdermal patches because the release liner may be difficult to remove.