FDA recall D-0471-2023

Product

Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5553-3

Reason for recall

Defective Delivery System: Out of specification for shear.

Distribution

US Nationwide

Key facts

Status

Ongoing

Initiation date

2023-03-10

Report date

2023-03-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0471-2023