FDAFDA · Food and drugs·Recall number D-0071-2023
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.
Published December 7, 2022 · Recall initiated: November 16, 2022
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: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DAYTRANA
- Manufacturer
- Noven Pharmaceuticals Inc
- Distributor
- Nationwide in the USA
- Lot
- Lot: 91316 Exp. 02/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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