CLASS III Device recall · Reported 12 Jan 2022 · FDA Enforcement Report
iontoPATCH On-the-Go Patch Therapy recalled by Tapemark
Tapemark is recalling iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra, distributed nationwide in the US. The recall was initiated on 10 Nov 2021 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0454-2022
- FDA event ID
- 89161
- Recalling firm
- Tapemark, Saint Paul, MN
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 10 Nov 2021
- FDA classified
- 5 Jan 2022
- Reported
- 12 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 10 Nov 2021 | Recall initiated by company | |
| 5 Jan 2022 | Classified by FDA | +56 days |
| 12 Jan 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The dosage information on the pouch is incorrect; the primary carton label is correct.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of CA, FL, IL, MO, NY, OH, and TN.
Nationwide CaliforniaFloridaIllinoisMissouriNew YorkOhioTennessee
Questions about this recall
Is iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra recalled?
Yes. Tapemark recalled iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra on 10 Nov 2021. The recall is Class III and its status is Terminated. Recall number Z-0454-2022.
Why was it recalled?
The dosage information on the pouch is incorrect; the primary carton label is correct.
Which lots are affected?
Lot numbers 1131-1 and 1131-2
Where was it sold?
US Nationwide distribution in the states of CA, FL, IL, MO, NY, OH, and TN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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