PlainRecalls
FDA Drug Moderate Class II Terminated

Daytrana (methylphenidate transdermal system), Delivers 30 mg over 9 hours (3.3mg/hr), CII, 30 patches per box, Manufactured for Noven Therapeutics LLC, Miami, FL 33186, by Noven Pharmaceuticals Inc., Miami, FL 33186, NDC # 68968-5555-3

Reported: June 3, 2015 Initiated: January 12, 2015 #D-1086-2015

Product Description

Daytrana (methylphenidate transdermal system), Delivers 30 mg over 9 hours (3.3mg/hr), CII, 30 patches per box, Manufactured for Noven Therapeutics LLC, Miami, FL 33186, by Noven Pharmaceuticals Inc., Miami, FL 33186, NDC # 68968-5555-3

Reason for Recall

Defective Delivery System: One lot exceeded the mechanical peel specification

Details

Units Affected
125,340 Patches
Distribution
Nationwide
Location
Miami, FL

Frequently Asked Questions

What product was recalled?
Daytrana (methylphenidate transdermal system), Delivers 30 mg over 9 hours (3.3mg/hr), CII, 30 patches per box, Manufactured for Noven Therapeutics LLC, Miami, FL 33186, by Noven Pharmaceuticals Inc., Miami, FL 33186, NDC # 68968-5555-3. Recalled by Noven Pharmaceuticals, Inc.. Units affected: 125,340 Patches.
Why was this product recalled?
Defective Delivery System: One lot exceeded the mechanical peel specification
Which agency issued this recall?
This recall was issued by the FDA Drug on June 3, 2015. Severity: Moderate. Recall number: D-1086-2015.