FDA (Drugs) recall action 75450
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 and/or the z-statistic values.
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 Daytrana (methylphenidate) transdermal patches because the delivery system failed to meet mechanical specifications.
Noven Pharmaceuticals is recalling 1,068,600 Daytrana transdermal patches nationwide because the delivery system failed mechanical peel force specifications.
Noven Pharmaceuticals is recalling Daytrana (methylphenidate) transdermal patches because the delivery system failed to meet mechanical peel force specifications.