Saint Paul, MN, United States
Tapemark Company recalls
1 recall recorded since 2018, most recently on 10 November 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class III Medical devices
- Recall started
- 10 November 2021
- Terminated
- 1 February 2023
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.