D-0071-2023 Class II Ongoing
FDA drug recall D-0071-2023 was initiated by Noven Pharmaceuticals Inc on November 16, 2022 and is designated Class II. Reason for recall: 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 recall status is ongoing. Affected quantity: 3977 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- December 7, 2022
- Initiation Date
- November 16, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3977 boxes
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 91316 Exp. 02/2023