Class II
Ongoing
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.
This recall is currently active, issued June 2, 2021. It was issued by Noven Pharmaceuticals, Inc..
- Company
- Noven Pharmaceuticals, Inc.
- Recall Initiated
- May 20, 2021
- Posted
- June 2, 2021
- Recall Number
- D-0393-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 9,587 boxes
- Firm Location
- Miami, FL, United States
- Official Source
- View on FDA website ↗
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
Nationwide in the USA
Lot / Code Info
Lot: 88528 Exp. 09/2021
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