Drug Enforcement D-0071-2023

Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.

Status

Ongoing

Classification

Class II

Report Date

December 7, 2022

Termination Date

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Product Information

Product description
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.
Product quantity
3977 boxes
Reason for recall
Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Noven Pharmaceuticals Inc
Address
11960 Sw 144th St

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0071-2023
Event ID
91161
Recall initiation date
November 16, 2022
Center classification date
November 28, 2022
Code info
Lot: 91316 Exp. 02/2023
More code info
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