Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 pouches/box. Dosage: 120mA/min.

U.S. FDA — Device Enforcement · United States · 2021-11-10 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0454-2022
Date of alert
2021-11-10
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Tapemark Company
Product category
device
Product type
Devices
Reported risk: The dosage information on the pouch is incorrect; the primary carton label is correct.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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