Noven Recalls Daytrana Patches Due to Defective Delivery System
Noven Pharmaceuticals is recalling Daytrana (methylphenidate) transdermal patches because the release liner may be difficult to remove.
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 hazard involves a functional defect in the delivery system (difficulty removing the liner) rather than a direct toxicological or structural safety failure.
Plain-English summary
Noven Pharmaceuticals, Inc. is recalling 335,910 patches of Daytrana (methylphenidate) transdermal system. The product is a prescription-only medication that delivers 10 mg of methylphenidate over 9 hours. The specific lot involved is #59824 with an expiration date of 04/13.
The recall was initiated due to out-of-specification results for the z-statistic value, which relates to the ability of patients and caregivers to remove the release liner from the patch adhesive prior to administration. This defect in the delivery system may interfere with the proper application of the patch.
The affected product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should stop using the recalled patches and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- DAYTRANA (METHYLPHENIDATE)
- Brand
- DAYTRANA
- Manufacturer
- Noven Pharmaceuticals, Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 335,910
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 (2)
- Lot #59824
- Exp 04/13
Distribution
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