Product Safety Recalls

Product Recall Tracker

METHYLPHENIDATE Recall D-0889-2022

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

METHYLPHENIDATE Recall D-0889-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0889-2022
Event ID90162
BrandDAYTRANA
Generic NameMETHYLPHENIDATE
ManufacturerMETHYLPHENIDATE
Original Package?1
Active SubstanceMETHYLPHENIDATE
Drug RouteTRANSDERMAL
DistributionNationwide to the U.S. Market
Quantity274, 110 patches
Recall ReasonDefective Delivery System: customer complaints exceeded respective action limits.
Drug ClassificationClass II
Drug Code Info20220601
Product NDC68968-5552 68968-5553 68968-5554
Product NUIN0000175739 N0000175729
Pharma Class (PE)Central Nervous System Stimulation [PE]
Pharma Class (EPC)Central Nervous System Stimulant [EPC]
Recall Initiation Date20220506
Report Date20220601
Classification Date20220520
Address11960 Sw 144th St
Miami, FL 33186-6109
United States
Recalling FirmNoven Pharmaceuticals Inc
Initial Notification Letter
Unique Ingredient Identifier207ZZ9QZ49
Drug Application NumberNDA021514
Structured Product Labeling (SPL ID)21f33a3c-6b65-4de2-9875-8f59c0d52e6b
Structured Product Labeling (SPL Set ID)2c312c31-3198-4775-91ab-294e0b4b9e7f
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