FDAClass IIIJanuary 12, 2022

iontoPATCH On-the-Go Patch Therapy recall

iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box.…

Why was iontoPATCH On-the-Go Patch Therapy recalled?

The dosage information on the pouch is incorrect; the primary carton label is correct.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot numbers 1131-1 and 1131-2

Product
iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box.…
Recalling firm
Tapemark Company
Quantity
5,141 primary cartons
Distribution
US Nationwide distribution in the states of CA, FL, IL, MO, NY, OH, and TN.
Recall date
January 12, 2022
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls