Noven Recalls Daytrana Patches Due to Defective Delivery System
Noven Pharmaceuticals is recalling Daytrana (methylphenidate) transdermal patches because the delivery system failed to meet mechanical 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 source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity rating.
Plain-English summary
Noven Pharmaceuticals, Inc. is recalling 364,830 Daytrana (methylphenidate) transdermal patches. The product is a prescription medication packaged in 30-count boxes. The recall covers specific lots with expiration dates of 02/2017 and 07/2016.
The recall was initiated because the patches produced out-of-specification results for the mechanical peel force and/or z-statistic values. These defects indicate that the delivery system may not function as intended. The affected patches were distributed nationwide within the United States.
Consumers who have the recalled Daytrana patches should stop using them and contact their healthcare provider or pharmacist for further instructions. The recall is classified as FDA Class II.
The recalled product
- Product
- DAYTRANA (METHYLPHENIDATE)
- Brand
- DAYTRANA
- Manufacturer
- Noven Pharmaceuticals, Inc.
- Category
- Drug — Transdermal Patch
- Affected units
- 364,830
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 (4)
- Lot #: 79230
- Exp. 02/2017
- 77547
- Exp.07/2016
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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 3 products in this recall →Related recalls
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