Drug recall D-0394-2021
Product
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.
Lots and codes
Lot: 88530 Exp. 10/2021
Recall details
- Recalling firm
- Noven Pharmaceuticals Inc, Miami, FL
- Quantity
- 6,689 boxes
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 20, 2021
Related products
- Daytrana – drug information
- NDC 68968-5554 Daytrana · Methylphenidate 20 mg/9h · Noven Therapeutics, LLC
- NDC 68968-5555 Daytrana · Methylphenidate 30 mg/9h · Noven Therapeutics, LLC
- NDC 68968-5553 Daytrana · Methylphenidate 15 mg/9h · Noven Therapeutics, LLC
- NDC 68968-5552 Daytrana · Methylphenidate 10 mg/9h · Noven Therapeutics, LLC