Z-0454-2022Class III

iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR...

Name: Z-0454-2022 iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR...
Creator: Tapemark Company
Published: 2021-11-10
License: https://open.fda.gov/license/

LTS Therapy Systems, LLC / initiated 2021-11-10 / Terminated / root cause: labeling and UDI

FDA source

Tapemark Company began a recall of iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box. Dosage... on 2021-11-10. FDA classified it as Class III and gives the reason as "The dosage information on the pouch is incorrect; the primary carton label is correct". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0454-2022
Classification: Class III
Status: Terminated
Initiated: 2021-11-10
Posted: 2022-01-05
Terminated: 2023-02-01
Recalling firm: LTS Therapy Systems, LLC
Product: 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.
Product code: EGJ Device, Iontophoresis, Other Uses
Reason for recall: The dosage information on the pouch is incorrect; the primary carton label is correct.
Root cause tag: labeling and UDI
FDA 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 necessary for their customers since the patch performs as described on the labeled box. On 11/30/2021, Tapemark issued another email to their consignees containing a recall letter dated 30NOV2021 and a subdistributor notification and acknowledgment dated 29NOV2021. The email says Tapemark is recalling the affected lot numbers due to the pouch being labeled incorrectly. Tapemark's consignee is to notify their customers by forwarding the email containing the subdistributor notification and acknowledgment form and to cease distribution. Tapemark's consignee is to let the them, Tapemark, know the quantity sent to the customer and the quantity they have remaining by 12/3/2021. The consignee's customer is to return their remaining inventory to Tapemark. Acknowledgment forms were enclosed with both the consignee letter and the subdistributor letter.
Quantity in commerce: 5,141 primary cartons
Distribution: US Nationwide distribution in the states of CA, FL, IL, MO, NY, OH, and TN.
Product codes and lots: Lot numbers 1131-1 and 1131-2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0454-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0454-2022	Class III	Terminated	Voluntary: Firm initiated	2022-01-12	2022-01-05

Product code EGJ

K992708Class IIIontopatchBirch Point Medical, Inc. / cleared 2000-02-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)