Multi event Drug Recall Enforcement Report Class II voluntary initiated by Noven Pharmaceuticals Inc, originally initiated on 02-19-2021 for the product Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5555-3. The product was recalled due to defective delivery system: out of specification for mechanical peel.. 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-0296-2021 | 02-19-2021 | 03-10-2021 | Class II | 934,140 patches | Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5555-3. | Defective Delivery System: Out of specification for mechanical peel. | Terminated |
| D-0293-2021 | 02-19-2021 | 03-10-2021 | Class II | 473,280 patches | Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5552-3. | Defective Delivery System: Out of specification for mechanical peel. | Terminated |
| D-0294-2021 | 02-19-2021 | 03-10-2021 | Class II | 551,670 patches | Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches in in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5553-3. | Defective Delivery System: Out of specification for mechanical peel. | Terminated |
| D-0295-2021 | 02-19-2021 | 03-10-2021 | Class II | 786,900 patches | Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5554-3. | Defective Delivery System: Out of specification for mechanical peel. | Terminated |
Recalled Products
