D-0394-2021 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- June 2, 2021
- Initiation Date
- May 20, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,689 boxes
Product Description
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), 30 Patches (NDC 68968-5553-1) per box (NDC 68968-5553-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186.
Reason for Recall
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 88530 Exp. 10/2021