Noven Pharmaceuticals Inc: Drug Recall
Recall #D-0394-2021 · 05/20/2021
Class II: Risk
Recall Details
- Recall Number
- D-0394-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Noven Pharmaceuticals Inc
- Status
- Ongoing
- Date Initiated
- 05/20/2021
- Location
- Miami, FL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,689 boxes
Reason for Recall
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
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.
Distribution Pattern
Nationwide in the USA
Other Recalls by Noven Pharmaceuticals Inc
- Class II: Risk 10/31/2024
- Class II: Risk 03/10/2023
- Class II: Risk 03/10/2023
- Class II: Risk 03/10/2023
- Class II: Risk 03/10/2023
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.