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.
Reported: January 12, 2022 Initiated: November 10, 2021 #Z-0454-2022
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.
Details
- Recalling Firm
- Tapemark Company
- Units Affected
- 5,141 primary cartons
- Distribution
- US Nationwide distribution in the states of CA, FL, IL, MO, NY, OH, and TN.
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Tapemark Company. Units affected: 5,141 primary cartons.
Why was this product recalled? ▼
The dosage information on the pouch is incorrect; the primary carton label is correct.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 12, 2022. Severity: Low. Recall number: Z-0454-2022.
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