Recall Z-0454-2022 ยท EGJ Device, Iontophoresis, Other Uses
Tapemark Company
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.
| Date | Nov 10, 2021 |
| Status | Terminated |
| Reason | The dosage information on the pouch is incorrect; the primary carton label is correct. |
| Root cause | Labeling Change Control |
| Action | Tapemark issued an email on 11/10/2021 to their consignees explaining the pouch dosage is labeled incorrectly as 80 mA/min but the box is labeled correctly with a dosage of 120mA/min. In addition, the patches within the pouch are the 120mA/min patches for the the correct wear time. The email requests the consignee place the affected product on hold and not fill any orders with it, and Tapemark will provide another letter to pass onto their downstream customers who received the affected product to alert them of the mislabeling information. The email goes on to say no corrective action is nec |
| Quantity | 5,141 primary cartons |
| Distribution | US Nationwide distribution in the states of CA, FL, IL, MO, NY, OH, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992708 | IONTOPATCH Birch Point Medical, Inc., Feb 1, 2000 |