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Noven Pharmaceuticals Recalls
51 recalls on record · June 20, 2012 to November 27, 2024 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 18, 2017DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count pa
Hazard: Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
January 18, 2017DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count pa
Hazard: Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
January 18, 2017DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate transdermal system) Transdermal Patch, 10 mg over 9 hours (1.1mg/hr), packaged in- 30 count pe
Hazard: Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
July 20, 2016DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count pa
Hazard: 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.
July 20, 2016DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count pa
Hazard: 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.
July 20, 2016DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9 hours (1.6 mg/hr), packaged in 30-count pa
Hazard: 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.
October 14, 2015DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufacture
Hazard: Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.
June 3, 2015DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate transdermal system), Delivers 30 mg over 9 hours (3.3mg/hr), CII, 30 patches per box, Manufact
Hazard: Defective Delivery System: One lot exceeded the mechanical peel specification
April 22, 2015DrugsFDA
Noven Pharmaceuticals, Inc. recalls Minivelle (estradiol transdermal system) 0.05 mg/day, 8-count box, Rx only, Manufactured by Noven Pharmaceuticals, Inc.,
Hazard: Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
October 1, 2014DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate transdermal system) patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , package
Hazard: 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.
March 26, 2014DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3mg/hr), 1patch per pouch , packaged
Hazard: 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.
March 26, 2014DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , package
Hazard: 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.
May 8, 2013DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch, package
Hazard: 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.
August 29, 2012DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch, package
Hazard: 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 release liner from the patch adhesive prior to administration.
August 29, 2012DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch, package
Hazard: 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 release liner from the patch adhesive prior to administration.
August 29, 2012DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, package
Hazard: 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 release liner from the patch adhesive prior to administration.
July 18, 2012DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68
Hazard: Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value
June 20, 2012DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch (NDC 540
Hazard: 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 release liner from the patch adhesive prior to administration.
June 20, 2012DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch (NDC 540
Hazard: 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 release liner from the patch adhesive prior to administration.
June 20, 2012DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch (NDC 540
Hazard: 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 release liner from the patch adhesive prior to administration.
June 20, 2012DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, package
Hazard: 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 release liner from the patch adhesive prior to administration.