Tapemark Company Recall 89161
Description: 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 Recall 89161 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0454-2022 |
| Event ID | 89161 |
| Event Description | 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 Type | Devices |
| Distribution | US Nationwide distribution in the states of CA, FL, IL, MO, NY, OH, and TN. |
| Quantity | 5,141 primary cartons |
| Recall Reason | The dosage information on the pouch is incorrect; the primary carton label is correct. |
| Device Classification | 20220112 |
| Device Code Info | Lot numbers 1131-1 and 1131-2 |
| Center Classification Date | 20220105 |
| Recall Initiation Date | 20211110 |
| Recalling Firm | Tapemark Company |
| Initial Notification | |
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