iontoPATCH On-the-Go Patch Therapy — Class III medical device recall Z-0454-2022
Terminated recall by Tapemark Company, reported 2022-01-12, distributed nationwide. The dosage information on the pouch is incorrect; the primary carton label is correct.
| Recall number | Z-0454-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tapemark Company, Saint Paul, MN, United States |
| Recall initiated | 2021-11-10 |
| Classified | 2022-01-05 |
| Reported by FDA | 2022-01-12 |
| Terminated | 2023-02-01 |
| Distributed | Nationwide (US) |
| Quantity | 5,141 primary |
| Reason classes | labeling |
| Lot numbers | 1131-1, 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. Dosage: 120mA/min.
Reason for recall
The dosage information on the pouch is incorrect; the primary carton label is correct.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0454-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.