Recall Z-0454-2022

Reason for recall

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

FDA-determined cause: Labeling Change Control

Action taken

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.