FDA recall D-0627-2018

Product

Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches Rx Only NDC 68968-5552-3 Manufactured for Noven Therapeutics, LLC., Miami, FL 33186 by Noven Pharmaceuticals, Inc. Miami, FL 33186 1-877-567-7857

Reason for recall

Defective Delivery System: Out of specification for adhesive transfer.

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2018-04-09

Report date

2018-04-25

Termination date

2020-01-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0627-2018