The FDA announced on Feb. 13, 2014, that Noven Pharmaceuticals Inc. voluntarily recalled Daytrana transdermal patches due to a defective delivery system. The hazard involves out-of-specification results for the z-statistic value related to liner removal. This Class II recall affects 117,600 units distributed nationwide.
How to tell if you have it
- Brand: Daytrana
- Product: Daytrana Transdermal Patch 30 mg
- Dosage: Delivers 30 mg over 9 hours (3.3mg/hr)
- Packaging: 1 patch per pouch, 30-count patches per box
- NDC: 68968-5555-3
- Lot Code: #70132
- Expiration Date: Exp. 09/14
The hazard
According to the FDA, the recall was initiated because defective delivery system results were obtained for the z-statistic value. This out-of-specification issue relates to the ability of patients and caregivers to remove the release liner from the patch adhesive prior to administration.
Context
GovInfoNow's records show Noven Pharmaceuticals Inc has 24 other recalls on record since 2011-07-05. Other recent recalls include a Noven Xelstrym 13.5mg Transdermal System recall on 2024-10-31 for defective adhesive risk and a Noven Daytrana 10mg Transdermal System recall on 2023-03-10 for out-of-specification shear. Similar recent recalls of other products include an Xyvona (Levorphanol) 2mg Tablet recall on 2026-05-22 and Wells Pharma Fentanyl Citrate Injectable Solution recalls on 2026-04-01.