FDA recall D-1086-2015

Product

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-01-12

Report date

2015-06-03

Termination date

2019-03-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1086-2015