FDA recall D-1249-2020

Product

Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5555-3

Reason for recall

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

Distribution

Distributed Nationwide in the US

Key facts

Status

Terminated

Initiation date

2020-03-31

Report date

2020-04-29

Termination date

2024-06-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1249-2020