FDA recall D-0889-2022

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 exceeded respective action limits.

Distribution

Nationwide to the U.S. Market

Key facts

Status

Ongoing

Initiation date

2022-05-06

Report date

2022-06-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0889-2022