Recall Enforment Report D-0071-2023
Drug Recall Enforcement Report Class II voluntary initiated by Noven Pharmaceuticals Inc, originally initiated on 11-16-2022 for the product Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, 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: recalled lot was found to be out of specification for shear. shear is an attribute related to the adhesive properties of the transdermal patches.. The product was distributed nationwide and the recall is currently ongoing.
Recalled Products
NDC | Proprietary Name | Non-Proprietary Name | Dosage Form | Route Name | Company Name | Product Type |
---|---|---|---|---|---|---|
68968-5552 | Daytrana | Methylphenidate | Patch | Transdermal | Noven Therapeutics, Llc | Human Prescription Drug |
68968-5553 | Daytrana | Methylphenidate | Patch | Transdermal | Noven Therapeutics, Llc | Human Prescription Drug |
68968-5554 | Daytrana | Methylphenidate | Patch | Transdermal | Noven Therapeutics, Llc | Human Prescription Drug |
68968-5555 | Daytrana | Methylphenidate | Patch | Transdermal | Noven Therapeutics, Llc | Human Prescription Drug |