FDA recall D-0008-2016

Product

Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufactured for: Noven Therapies, LLC., Miami, FL 33186, by: Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC: 68968-5555-3

Reason for recall

Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.

Distribution

US Nationwide

Key facts

Status

Terminated

Initiation date

2015-07-27

Report date

2015-10-14

Termination date

2019-03-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0008-2016