FDAFDA · Food and drugs·Recall number D-0393-2021
Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), 30 Patches (NDC 68968-5552-1) per box (NDC 68968-5552-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186.
Published June 2, 2021 · Recall initiated: May 20, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DAYTRANA
- Manufacturer
- Noven Pharmaceuticals Inc
- Distributor
- Nationwide in the USA
- Lot
- Lot: 88528 Exp. 09/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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