PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: April 25, 2018 Initiated: April 9, 2018 #D-0627-2018

Product Description

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.

Details

Units Affected
9016 boxes of 30 patch each
Distribution
Nationwide.
Location
Miami, FL

Frequently Asked Questions

What product was recalled?
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. Recalled by Noven Pharmaceuticals, Inc.. Units affected: 9016 boxes of 30 patch each.
Why was this product recalled?
Defective Delivery System: Out of specification for adhesive transfer.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 25, 2018. Severity: Moderate. Recall number: D-0627-2018.