Noven Pharmaceuticals recalls
Noven Pharmaceuticals appears in 51 official U.S. recall notices indexed by RecallRadar, most recently on 2024-11-27.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 51 |
|---|---|
| Published | 2012-06-20 to 2024-11-27 |
| By agency | FDA Drug (51) |
| By classification | Class II (50), Class III (1) |
| By status | terminated (39), ongoing (12) |
| Distribution named in notices | US |
Recalls
- Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a fo…
FDA Drug · Class II · 2024-11-27 · Noven Pharmaceuticals
Reason: Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive). - Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Nove…
FDA Drug · Class II · 2023-03-29 · Noven Pharmaceuticals
Reason: Defective Delivery System: Out of specification for shear. - Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Nove…
FDA Drug · Class II · 2023-03-29 · Noven Pharmaceuticals
Reason: Defective Delivery System: Out of specification for shear. - Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Nov…
FDA Drug · Class II · 2023-03-29 · Noven Pharmaceuticals
Reason: Defective Delivery System: Out of specification for shear. - Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Nov…
FDA Drug · Class II · 2023-03-29 · Noven Pharmaceuticals
Reason: Defective Delivery System: Out of specification for shear. - Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for Nove…
FDA Drug · Class II · 2022-12-07 · Noven Pharmaceuticals
Reason: Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches. - Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven…
FDA Drug · Class II · 2022-07-06 · Noven Pharmaceuticals
Reason: Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer. - Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven…
FDA Drug · Class II · 2022-06-01 · Noven Pharmaceuticals
Reason: Defective Delivery System: customer complaints exceeded respective action limits. - Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968-0…
FDA Drug · Class II · 2021-08-25 · Noven Pharmaceuticals
Reason: Failed Stability Specifications; out of specification for shear. - Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Systems NDC 68968-052…
FDA Drug · Class II · 2021-08-25 · Noven Pharmaceuticals
Reason: Failed Stability Specifications; out of specification for shear. - Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), 30 Patches (NDC 68968-5552-1) per box (NDC 68968-55…
FDA Drug · Class II · 2021-06-02 · Noven Pharmaceuticals
Reason: Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits. - Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), 30 Patches (NDC 68968-5553-1) per box (NDC 68968-55…
FDA Drug · Class II · 2021-06-02 · Noven Pharmaceuticals
Reason: Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits. - Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc
FDA Drug · Class II · 2021-04-28 · Noven Pharmaceuticals
Reason: Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not… - Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc
FDA Drug · Class II · 2021-04-28 · Noven Pharmaceuticals
Reason: Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not… - Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene t…
FDA Drug · Class II · 2021-03-10 · Noven Pharmaceuticals
Reason: Defective Delivery System: Out of specification for mechanical peel. - Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches in in a foil-sealed polypropyl…
FDA Drug · Class II · 2021-03-10 · Noven Pharmaceuticals
Reason: Defective Delivery System: Out of specification for mechanical peel. - Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), Contains: 30 Patches in a foil-sealed polypropylene…
FDA Drug · Class II · 2021-03-10 · Noven Pharmaceuticals
Reason: Defective Delivery System: Out of specification for mechanical peel. - Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene t…
FDA Drug · Class II · 2021-03-10 · Noven Pharmaceuticals
Reason: Defective Delivery System: Out of specification for mechanical peel. - Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc
FDA Drug · Class II · 2018-10-03 · Noven Pharmaceuticals
Reason: Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. - Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. by: Noven Pharmaceut…
FDA Drug · Class II · 2018-10-03 · Noven Pharmaceuticals
Reason: Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. - Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc
FDA Drug · Class II · 2018-10-03 · Noven Pharmaceuticals
Reason: Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. - Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only, Mfd. by: Noven Pharmaceutica…
FDA Drug · Class II · 2018-10-03 · Noven Pharmaceuticals
Reason: Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. - Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC 68968-6610-1), packaged in 8 pouches per box (NDC 68968-6610-8…
FDA Drug · Class II · 2018-05-16 · Noven Pharmaceuticals
Reason: Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well t… - Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (NDC 68968-6637-1), packaged in 8 pouches per box (NDC 68968-663…
FDA Drug · Class II · 2018-05-16 · Noven Pharmaceuticals
Reason: Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well t… - Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches Rx Only NDC 68968-5552-3 Manufac…
FDA Drug · Class II · 2018-04-25 · Noven Pharmaceuticals
Reason: Defective Delivery System: Out of specification for adhesive transfer. - Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven…
FDA Drug · Class II · 2017-09-27 · Noven Pharmaceuticals
Reason: Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic. - Daytrana (methylphenidate transdermal system) Delivers 15 mg over 9 hours (1.6 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven…
FDA Drug · Class II · 2017-09-27 · Noven Pharmaceuticals
Reason: Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic. - Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven…
FDA Drug · Class II · 2017-09-27 · Noven Pharmaceuticals
Reason: Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic. - Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven…
FDA Drug · Class II · 2017-09-27 · Noven Pharmaceuticals
Reason: Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic. - Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, F…
FDA Drug · Class III · 2017-07-05 · Noven Pharmaceuticals
Reason: Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH. - Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx o…
FDA Drug · Class II · 2017-01-18 · Noven Pharmaceuticals
Reason: Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values. - Daytrana (methylphenidate transdermal system) Transdermal Patch, 10 mg over 9 hours (1.1mg/hr), packaged in- 30 count per box, Rx only, Man…
FDA Drug · Class II · 2017-01-18 · Noven Pharmaceuticals
Reason: Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values. - Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx o…
FDA Drug · Class II · 2017-01-18 · Noven Pharmaceuticals
Reason: Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values. - Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9 hours (1.6 mg/hr), packaged in 30-count patches per box, Rx o…
FDA Drug · Class II · 2016-07-20 · Noven Pharmaceuticals
Reason: 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 adhe… - Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx o…
FDA Drug · Class II · 2016-07-20 · Noven Pharmaceuticals
Reason: 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 adhe… - Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx o…
FDA Drug · Class II · 2016-07-20 · Noven Pharmaceuticals
Reason: 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 adhe… - Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufactured for: Noven Therap…
FDA Drug · Class II · 2015-10-14 · Noven Pharmaceuticals
Reason: Defective Delivery System: Out of specification for z-statistic related to mechanical peel force. - Daytrana (methylphenidate transdermal system), Delivers 30 mg over 9 hours (3.3mg/hr), CII, 30 patches per box, Manufactured for Noven Ther…
FDA Drug · Class II · 2015-06-03 · Noven Pharmaceuticals
Reason: Defective Delivery System: One lot exceeded the mechanical peel specification - Minivelle (estradiol transdermal system) 0.05 mg/day, 8-count box, Rx only, Manufactured by Noven Pharmaceuticals, Inc., Miami, Florida 331…
FDA Drug · Class II · 2015-04-22 · Noven Pharmaceuticals
Reason: Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions. - Daytrana (methylphenidate transdermal system) patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patch…
FDA Drug · Class II · 2014-10-01 · Noven Pharmaceuticals
Reason: 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 adhe… - Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3mg/hr), 1patch per pouch , packaged in 30-count patche…
FDA Drug · Class II · 2014-03-26 · Noven Pharmaceuticals
Reason: 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, w… - Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patch…
FDA Drug · Class II · 2014-03-26 · Noven Pharmaceuticals
Reason: 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, w… - Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch, packaged in 30-count patch…
FDA Drug · Class II · 2013-05-08 · Noven Pharmaceuticals
Reason: 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, w… - Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch, packaged in 30-count patch…
FDA Drug · Class II · 2012-08-29 · Noven Pharmaceuticals
Reason: 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 adhes… - Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patch…
FDA Drug · Class II · 2012-08-29 · Noven Pharmaceuticals
Reason: 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 adhes… - Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch, packaged in 30-count patch…
FDA Drug · Class II · 2012-08-29 · Noven Pharmaceuticals
Reason: 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 adhes… - Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68968-5554-01) packag…
FDA Drug · Class II · 2012-07-18 · Noven Pharmaceuticals
Reason: Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value - Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch (NDC 54092-553-01), package…
FDA Drug · Class II · 2012-06-20 · Noven Pharmaceuticals
Reason: 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 adhes… - Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch (NDC 54092-555-01), package…
FDA Drug · Class II · 2012-06-20 · Noven Pharmaceuticals
Reason: 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 adhes… - Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patch…
FDA Drug · Class II · 2012-06-20 · Noven Pharmaceuticals
Reason: 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 adhes…