FDA Device recall Z-0454-2022
iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pou…
- FDA Device
- Class III
- terminated
- Published 2022-01-12
On 2022-01-12 the FDA classified a Class III recall of iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pou… by Tapemark, citing the dosage information on the pouch is incorrect; the primary carton label is correct.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0454-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-11-10 |
| Published | 2022-01-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Tapemark |
| Distribution | US |
Product
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.
Reason
The dosage information on the pouch is incorrect; the primary carton label is correct.
Identifiers
| code_info | Lot numbers 1131-1 and 1131-2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0454-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.