iontoPATCH On-the-Go transdermal patch has incorrect dosage information on pouch
Tapemark's iontoPATCH On-the-Go patches contain incorrect dosage information printed on the pouch label, though the primary carton label is correct. Approximately 5,141 cartons were distributed nationwide.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall involving a labeling discrepancy on medical device packaging. No reported illnesses or injuries. While the incorrect pouch label could create patient confusion, the correct information is available on the primary carton, mitigating risk.
Plain-English summary
The FDA is recalling iontoPATCH On-the-Go Patch Therapy, a transdermal iontophoretic drug delivery system manufactured by Tapemark Company. The recall involves approximately 5,141 primary cartons with lot numbers 1131-1 and 1131-2. The dosage information printed on the individual patch pouches is incorrect, while the primary carton label is correct.
The incorrect pouch labeling could potentially lead to patient confusion regarding proper device use. The correct dosage information remains available on the primary carton packaging.
This is a Class III recall with no reported injuries or illnesses. If you have purchased affected lots, verify dosage information on the primary carton label and do not rely solely on the pouch label. Contact Tapemark Company or your healthcare provider with any questions about proper use.
Affected lots were distributed nationwide to California, Florida, Illinois, Missouri, New York, Ohio, and Tennessee.
The recalled product
- 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.
- Manufacturer
- Tapemark Company
- Hazard
- Affected units
- 5,141
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot numbers 1131-1 and 1131-2
Distribution
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