iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear
Summary
The FDA issued a Class III for iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery Syst by Tapemark Company. Reason: The dosage information on the pouch is incorrect; the primary carton label is correct..
Details
Source
Device Recall
External ID
Z-0454-2022
Action Date
2022-01-12
Status
Terminated
Category
device
Product Description
iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box. Dosage: 120mA/min.
Lot/Code Info: Lot numbers 1131-1 and 1131-2
Quantity Affected: 5,141 primary cartons
Reason for Recall
The dosage information on the pouch is incorrect; the primary carton label is correct.
Distribution
US Nationwide distribution in the states of CA, FL, IL, MO, NY, OH, and TN.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-10
Company
Saint Paul, MN
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 114 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Tapemark Company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Tapemark Company have FDA actions?
This is the only FDA action we have on record for Tapemark Company in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0454-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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