FDA recall D-1169-2022

Product

Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5552-3

Reason for recall

Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.

Distribution

Distributed Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2022-06-24

Report date

2022-07-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1169-2022