Tapemark Company: Medical Device Recall in 2022 - (Recall #: Z-0454-2022)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2022.
Data Source: FDA.
Product Description:
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.
Product Classification:
Class III
Date Initiated: November 10, 2021
Date Posted: January 12, 2022
Recall Number: Z-0454-2022
Event ID: 89161
Reason for Recall:
The dosage information on the pouch is incorrect; the primary carton label is correct.
Status: Terminated
Product Quantity: 5,141 primary cartons
Code Information:
Lot numbers 1131-1 and 1131-2
Distribution Pattern:
US Nationwide distribution in the states of CA, FL, IL, MO, NY, OH, and TN.
Voluntary or Mandated:
Voluntary: Firm initiated