PlainRecalls
FDA Drug Moderate Class II Terminated

Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 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 68968-5555-3.

Reported: March 10, 2021 Initiated: February 19, 2021 #D-0296-2021

Product Description

Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 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 68968-5555-3.

Reason for Recall

Defective Delivery System: Out of specification for mechanical peel.

Details

Recalling Firm
Noven Pharmaceuticals Inc
Units Affected
934,140 patches
Distribution
Nationwide in the USA
Location
Miami, FL

Frequently Asked Questions

What product was recalled?
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 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 68968-5555-3.. Recalled by Noven Pharmaceuticals Inc. Units affected: 934,140 patches.
Why was this product recalled?
Defective Delivery System: Out of specification for mechanical peel.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 10, 2021. Severity: Moderate. Recall number: D-0296-2021.