FDA-Device2022-01-12Class III
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.
Tapemark Company
Hazard
The dosage information on the pouch is incorrect; the primary carton label is correct.
Sold states
US Nationwide distribution in the states of CA, FL, IL, MO, NY, OH, and TN.
Affected count
5,141 primary cartons
Manufactured in
1685 Marthaler Ln, N/A, Saint Paul, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0454-2022Don't want to check this manually?
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