DrugSep 27, 2017
Daytrana recall — FDA D-1169-2017
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Class IIFDA: TerminatedNoven Pharmaceuticals, Inc.
Recall history in this database
Classification mix: Class II: 45, Class III: 1.
DrugJul 5, 2017
Minivelle recall — FDA D-0923-2017
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
Class IIIFDA: TerminatedNoven Pharmaceuticals, Inc.
DrugJan 18, 2017
Daytrana recall — FDA D-0429-2017
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Class IIFDA: TerminatedNoven Pharmaceuticals, Inc.
DrugJan 18, 2017
Daytrana recall — FDA D-0430-2017
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Class IIFDA: TerminatedNoven Pharmaceuticals, Inc.
DrugJan 18, 2017
Daytrana recall — FDA D-0428-2017
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Class IIFDA: TerminatedNoven Pharmaceuticals, Inc.
DrugJul 20, 2016
Daytrana recall — FDA D-1439-2016
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…
Class IIFDA: TerminatedNoven Pharmaceuticals, Inc.
DrugJul 20, 2016
Daytrana recall — FDA D-1438-2016
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…
Class IIFDA: TerminatedNoven Pharmaceuticals, Inc.
DrugJul 20, 2016
Daytrana recall — FDA D-1440-2016
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…
Class IIFDA: TerminatedNoven Pharmaceuticals, Inc.
DrugOct 14, 2015
Daytrana recall — FDA D-0008-2016
Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.
Class IIFDA: TerminatedNoven Pharmaceuticals, Inc.
DrugJun 3, 2015
Daytrana recall — FDA D-1086-2015
Defective Delivery System: One lot exceeded the mechanical peel specification
Class IIFDA: TerminatedNoven Pharmaceuticals, Inc.
DrugOct 1, 2014
Daytrana recall — FDA D-1608-2014
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…
Class IIFDA: TerminatedNoven Pharmaceuticals, Inc.
DrugMar 26, 2014
Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3mg/hr) recall — FDA D-1172-2014
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…
Class IIFDA: TerminatedNoven Pharmaceuticals, Inc.
DrugMar 26, 2014
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2mg/hr) recall — FDA D-1171-2014
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…
Class IIFDA: TerminatedNoven Pharmaceuticals, Inc.
DrugMay 8, 2013
Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours recall — FDA D-312-2013
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…
Class IIFDA: TerminatedNoven Pharmaceuticals, Inc.
DrugAug 29, 2012
Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours recall — FDA D-1655-2012
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…
Class IIFDA: TerminatedNoven Pharmaceuticals, Inc.
DrugAug 29, 2012
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours recall — FDA D-1653-2012
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…
Class IIFDA: TerminatedNoven Pharmaceuticals, Inc.
DrugAug 29, 2012
Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours recall — FDA D-1654-2012
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…
Class IIFDA: TerminatedNoven Pharmaceuticals, Inc.
DrugJul 18, 2012
Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours recall — FDA D-1413-2012
Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value
Class IIFDA: TerminatedNoven Pharmaceuticals, Inc.
DrugJun 20, 2012
Noven Pharmaceuticals Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg recall — FDA D-1374-2012
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…
Class IIFDA: TerminatedNoven Pharmaceuticals, Inc.
DrugJun 20, 2012
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours recall — FDA D-1372-2012
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…
Class IIFDA: TerminatedNoven Pharmaceuticals, Inc.
DrugJun 20, 2012
Noven Pharmaceuticals Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg recall — FDA D-1375-2012
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…
Class IIFDA: TerminatedNoven Pharmaceuticals, Inc.
DrugJun 20, 2012
Noven Pharmaceuticals Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg recall — FDA D-1373-2012
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…
Class IIFDA: TerminatedNoven Pharmaceuticals, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Noven Pharmaceuticals, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.