Drug Enforcement D-0471-2023

Defective Delivery System: Out of specification for shear.

Status

Ongoing

Classification

Class II

Report Date

March 29, 2023

Termination Date

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Product Information

Product description
Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5553-3
Product quantity
N/A
Reason for recall
Defective Delivery System: Out of specification for shear.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
US Nationwide

Location & Firm

Recalling firm
Noven Pharmaceuticals Inc
Address
11960 Sw 144th St, N/A

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

Codes & Dates

Recall number
D-0471-2023
Event ID
91882
Recall initiation date
March 10, 2023
Center classification date
March 20, 2023
Code info
Lot#: 91956, Exp. 6/2023; 92475, Exp. 7/2023
More code info
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