FDA (Drugs) recall action 67718
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.
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.
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 187,860 Daytrana patches because the release liner may be difficult to remove. The defect affects the ability to apply the patch correctly.
Noven Pharmaceuticals is recalling Daytrana (methylphenidate) transdermal patches because out-of-specification results indicate the release liner may be difficult to remove.