FDA recall D-1044-2020

Product

Daytrana (methylphenidate transdermal system) patches, Delivers 20 mg over 9 hours (2.2 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5554-3

Reason for recall

Defective Delivery System: Out of specification for mechanical peel and shear.

Distribution

U.S.A. Nationwide

Key facts

Status

Terminated

Initiation date

2020-03-02

Report date

2020-03-25

Termination date

2023-05-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1044-2020