FDA (Drugs) recall action 78021
The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
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 products no longer meet release liner removal specifications.
Noven Pharmaceuticals is recalling Daytrana (methylphenidate) transdermal patches because they no longer meet release liner removal specifications.
Noven Pharmaceuticals is recalling 321,900 Daytrana patches because the delivery system no longer meets release liner removal specifications.
Noven Pharmaceuticals is recalling 182,850 Daytrana patches because they no longer meet release liner removal specifications.