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Noven Pharmaceuticals Inc FDA Recalls
18 recalls on file across drugs, 0 of them Class I and 12 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal pClass IIOct 31, 2024Defective Delivery System: The product does not meet predete |
| Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, Class IIMar 10, 2023Defective Delivery System: Out of specification for shear. |
| Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics,Class IIMar 10, 2023Defective Delivery System: Out of specification for shear. |
| Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, Class IIMar 10, 2023Defective Delivery System: Out of specification for shear. |
| Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics,Class IIMar 10, 2023Defective 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, MaClass IINov 16, 2022Defective Delivery System: Recalled lot was found to be out |
| Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, ManClass IIJun 24, 2022Defective Delivery System: Customer complaints received for |
| Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, ManClass IIMay 6, 2022Defective Delivery System: customer complaints exceeded resp |
| Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Class IIJul 30, 2021Failed Stability Specifications; out of specification for sh |
| Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 SyClass IIJul 30, 2021Failed Stability Specifications; out of specification for sh |
| Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), 30 Patches (NDC 68968-5552-1) peClass IIMay 20, 2021Defective Delivery System: The number of customer complaints |
| Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), 30 Patches (NDC 68968-5553-1) peClass IIMay 20, 2021Defective Delivery System: The number of customer complaints |
| Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Class IIApr 16, 2021Defective Delivery System: Out of specification for release |
| Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami,Class IIApr 16, 2021Defective Delivery System: Out of specification for release |
| Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches in in a foiClass IIFeb 19, 2021Defective Delivery System: Out of specification for mechanic |
| Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Contains: 30 Patches in a foil-seaClass IIFeb 19, 2021Defective Delivery System: Out of specification for mechanic |
| Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Contains: 30 Patches in a foil-seaClass IIFeb 19, 2021Defective Delivery System: Out of specification for mechanic |
| Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), Contains: 30 Patches in a foil-sClass IIFeb 19, 2021Defective Delivery System: Out of specification for mechanic |