Noven Pharmaceuticals, Inc.

FDA Regulatory Profile

Summary

Total Recalls
51
510(k) Clearances
0
Inspections
12
Compliance Actions
2

Recent Recalls

NumberClassProductDate
D-0055-2025Class IIXelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually October 31, 2024
D-0471-2023Class IIDaytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured forMarch 10, 2023
D-0472-2023Class IIDaytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for March 10, 2023
D-0473-2023Class IIDaytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured forMarch 10, 2023
D-0470-2023Class IIDaytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for March 10, 2023
D-0071-2023Class IIDaytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches November 16, 2022
D-1169-2022Class IIDaytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 PJune 24, 2022
D-0889-2022Class IIDaytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 PMay 6, 2022
D-0724-2021Class IICombipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice WJuly 30, 2021
D-0725-2021Class IICombipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice WeJuly 30, 2021
D-0394-2021Class IIDaytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), 30 Patches (May 20, 2021
D-0393-2021Class IIDaytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), 30 Patches (May 20, 2021
D-0336-2021Class IIMinivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: NovApril 16, 2021
D-0337-2021Class IIEstradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven PharmaceApril 16, 2021
D-0296-2021Class IIDaytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Contains: 30 PFebruary 19, 2021
D-0294-2021Class IIDaytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30February 19, 2021
D-0293-2021Class IIDaytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), Contains: 30February 19, 2021
D-0295-2021Class IIDaytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Contains: 30 PFebruary 19, 2021
D-1210-2018Class IIMinivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, MfdSeptember 7, 2018
D-1208-2018Class IIMinivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxesSeptember 7, 2018