Noven Recalls Daytrana Methylphenidate Patches Due to Defective Delivery System
Noven Pharmaceuticals is recalling Daytrana (methylphenidate) transdermal patches because the products no longer meet release liner removal specifications.
What this means for you
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: The recall is classified as FDA Class II, and the defect relates to the delivery system specifications without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Noven Pharmaceuticals, Inc. is recalling Daytrana (methylphenidate transdermal system) patches. The recall involves 234,960 patches of the 15 mg over 9 hours (1.6 mg/hr) prescription-only product, specifically Lot 80426 with an expiration date of 10/17. The product was distributed nationwide.
The recall was initiated because the products no longer meet the release liner removal specification and/or z-statistic. This indicates a defect in the delivery system of the transdermal patches.
Consumers and healthcare providers should stop using the affected Daytrana patches and contact their healthcare provider or Noven Pharmaceuticals for further instructions on how to return the product.
The recalled product
- Product
- DAYTRANA (METHYLPHENIDATE)
- Brand
- DAYTRANA
- Manufacturer
- Noven Pharmaceuticals, Inc.
- Category
- Drug — Transdermal Patch
- Affected units
- 234,960
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: 80426 Exp. 10/17
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Noven Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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