Noven Pharmaceuticals Inc: Drug Recall

Recall #D-0296-2021 · 02/19/2021

Class II: Risk

Recall Details

Recall Number
D-0296-2021
Classification
Class II
Product Type
Drug
Recalling Firm
Noven Pharmaceuticals Inc
Status
Terminated
Date Initiated
02/19/2021
Location
Miami, FL, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
934,140 patches

Reason for Recall

Defective Delivery System: Out of specification for mechanical peel.

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.

Distribution Pattern

Nationwide in the USA

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.