D-0889-2022 Class II Ongoing
FDA drug recall D-0889-2022 was initiated by Noven Pharmaceuticals Inc on May 6, 2022 and is designated Class II. Reason for recall: Defective Delivery System: customer complaints exceeded respective action limits. The recall status is ongoing. Affected quantity: 274, 110 patches.
Recall Details
- Product Type
- Drugs
- Report Date
- June 1, 2022
- Initiation Date
- May 6, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 274, 110 patches
Product Description
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5552-3
Reason for Recall
Defective Delivery System: customer complaints exceeded respective action limits.
Distribution Pattern
Nationwide to the U.S. Market
Code Information
Lot: 90764 Exp. 08/2022