Z-0454-2022 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 12, 2022
- Initiation Date
- November 10, 2021
- Termination Date
- February 1, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,141 primary cartons
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.
Reason for Recall
The dosage information on the pouch is incorrect; the primary carton label is correct.
Distribution Pattern
US Nationwide distribution in the states of CA, FL, IL, MO, NY, OH, and TN.
Code Information
Lot numbers 1131-1 and 1131-2