Tapemark Company recalls iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear…

Recall date

November 10, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0454-2022

FDA classification

Class III

Brand / firm

Tapemark Company

Sold / distributed

US Nationwide distribution in the states of CA, FL, IL, MO, NY, OH, and TN.

Why it was recalled

The dosage information on the pouch is incorrect; the primary carton label is correct.

Class III means the product violates regulations but is not likely to cause harm.

What 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.