FDA recall D-1171-2017

Product

Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Rx Only Contains: 30 Patches 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: Products no longer meet the release liner removal specification and/or z-statistic.

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2017-08-30

Report date

2017-09-27

Termination date

2020-01-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1171-2017