D-0470-2023 Class II Ongoing
FDA drug recall D-0470-2023 was initiated by Noven Pharmaceuticals Inc on March 10, 2023 and is designated Class II. Reason for recall: Defective Delivery System: Out of specification for shear. The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- March 29, 2023
- Initiation Date
- March 10, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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.
Reason for Recall
Defective Delivery System: Out of specification for shear.
Distribution Pattern
US Nationwide
Code Information
Lot#: 91955, Exp. 7/2023; 93039, Exp. 10/2023