Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured f...

FDA Recall #D-0472-2023 — Class II — March 10, 2023

Recall #D-0472-2023 Date: March 10, 2023 Classification: Class II Status: Ongoing

Product Description

Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5554-3.

Reason for Recall

Defective Delivery System: Out of specification for shear.

Recalling Firm

Noven Pharmaceuticals Inc — Miami, FL

Classification

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

Product Type

Drugs

Product Quantity

N/A

Distribution

US Nationwide

Code Information

Lot#: 91957, 92197, Exp. 7/2023; 92476, Exp. 9/2023; 92477, Exp. 10/2023

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated