Multi event Drug Recall Enforcement Report Class II voluntary initiated by Noven Pharmaceuticals Inc, originally initiated on 03-10-2023 for the product Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5553-3 The product was recalled due to defective delivery system: out of specification for shear.. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0471-2023 | 03-10-2023 | 03-29-2023 | Class II | N/A | Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5553-3 | Defective Delivery System: Out of specification for shear. | Ongoing |
| D-0473-2023 | 03-10-2023 | 03-29-2023 | Class II | N/A | Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5555-3 | Defective Delivery System: Out of specification for shear. | Ongoing |
| D-0472-2023 | 03-10-2023 | 03-29-2023 | Class II | N/A | Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5554-3. | Defective Delivery System: Out of specification for shear. | Ongoing |
| D-0470-2023 | 03-10-2023 | 03-29-2023 | Class II | N/A | Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5552-3. | Defective Delivery System: Out of specification for shear. | Ongoing |
Recalled Products
