Noven Pharmaceuticals Inc: Drug Recall
Recall #D-0071-2023 · 11/16/2022
Class II: Risk
Recall Details
- Recall Number
- D-0071-2023
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Noven Pharmaceuticals Inc
- Status
- Ongoing
- Date Initiated
- 11/16/2022
- Location
- Miami, FL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3977 boxes
Reason for Recall
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.
Product Description
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.
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.