Multi event Drug Recall Enforcement Report Class II voluntary initiated by Noven Therapeutics, LLC, originally initiated on 03-31-2020 for the product Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5554-3 The product was recalled due to defective delivery system: out of specification for mechanical peel and shear.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-1248-2020 | 03-31-2020 | 04-29-2020 | Class II | 5,614 30-count boxes | Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5554-3 | Defective Delivery System: Out of specification for mechanical peel and shear. | Terminated |
| D-1249-2020 | 03-31-2020 | 04-29-2020 | Class II | 14,142 30-count boxes | Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5555-3 | Defective Delivery System: Out of specification for mechanical peel and shear. | Terminated |
| D-1247-2020 | 03-31-2020 | 04-29-2020 | Class II | 7957 30-count boxes | Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5552-3 | Defective Delivery System: Out of specification for mechanical peel and shear. | Terminated |
Recalled Products
