Multi event Drug Recall Enforcement Report Class II voluntary initiated by Noven Pharmaceuticals, Inc., originally initiated on 08-30-2017 for the product Daytrana (methylphenidate transdermal system) Delivers 15 mg over 9 hours (1.6 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5553-3 The product was recalled due to defective delivery system: products no longer meet the release liner removal specification and/or z-statistic.. 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-1172-2017 | 08-30-2017 | 09-27-2017 | Class II | 234,960 patches | Daytrana (methylphenidate transdermal system) Delivers 15 mg over 9 hours (1.6 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5553-3 | Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic. | Terminated |
| D-1170-2017 | 08-30-2017 | 09-27-2017 | Class II | 182,850 patches | Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5554-3 | Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic. | Terminated |
| D-1169-2017 | 08-30-2017 | 09-27-2017 | Class II | 321,900 patches | Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5552-3 | Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic. | Terminated |
| D-1171-2017 | 08-30-2017 | 09-27-2017 | Class II | 331,950 patches | Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5555-3 | Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic. | Terminated |
Recalled Products
