Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 3...

FDA Recall #D-1169-2022 — Class II — June 24, 2022

Recall #D-1169-2022 Date: June 24, 2022 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.

Recalling Firm

Noven Pharmaceuticals Inc — Miami, FL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

8,559 cartons

Distribution

Distributed Nationwide in the USA

Code Information

Lot: 91272 Exp. 12/22.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated