# FDA recall Z-0454-2022

> **Tapemark Company** · Class III · device recall initiated 2021-11-10.

## 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.

## Distribution

US Nationwide distribution in the states of CA, FL, IL, MO, NY, OH, and TN.

## Key facts

- **Recall number:** Z-0454-2022
- **Recalling firm:** Tapemark Company
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-11-10
- **Report date:** 2022-01-12
- **Termination date:** 2023-02-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0454-2022

## Citation

> AI Analytics. FDA recall Z-0454-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0454-2022. Source: US FDA. Licensed CC0.

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