FDA recall D-1413-2012

Product

Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68968-5554-01) packaged in 3-count patches per box (NDC 68968-5554-3) , Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33816.08/04/12.

Reason for recall

Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2012-03-22

Report date

2012-07-18

Termination date

2014-05-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1413-2012