FDA recall D-0295-2021

Product

Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5554-3.

Reason for recall

Defective Delivery System: Out of specification for mechanical peel.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2021-02-19

Report date

2021-03-10

Termination date

2024-07-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0295-2021