Noven Therapeutics, LLC

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1249-2020Class IIDaytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, March 31, 2020
D-1247-2020Class IIDaytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box,March 31, 2020
D-1248-2020Class IIDaytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, March 31, 2020
D-1042-2020Class IIDaytrana (methylphenidate transdermal system) patches, Delivers 10 mg over 9 hours (1.1 mg/hr), 30-cMarch 2, 2020
D-1043-2020Class IIDaytrana (methylphenidate transdermal system) patches, Delivers 15 mg over 9 hours (1.6 mg/hr), 30-cMarch 2, 2020
D-1045-2020Class IIDaytrana (methylphenidate transdermal system) patches, Delivers 30 mg over 9 hours (3.3 mg/hr), 30-cMarch 2, 2020
D-1044-2020Class IIDaytrana (methylphenidate transdermal system) patches, Delivers 20 mg over 9 hours (2.2 mg/hr), 30-cMarch 2, 2020