Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Man
Summary
The FDA issued a Class II for Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 m by Noven Pharmaceuticals Inc. Reason: Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer..
Details
Source
Drug Recall
External ID
D-1169-2022
Action Date
2022-07-06
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot: 91272 Exp. 12/22.
Quantity Affected: 8,559 cartons
Reason for Recall
Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.
Distribution
Distributed Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-24
Company
Miami, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 29 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Noven Pharmaceuticals Inc has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Noven Pharmaceuticals Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Noven Pharmaceuticals Inc have FDA actions?
Noven Pharmaceuticals Inc has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1169-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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