Noven Recalls Daytrana Methylphenidate Patches Due to Defective Delivery System
Noven Pharmaceuticals is recalling 182,850 Daytrana patches because they 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 involves a delivery system specification failure without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Noven Pharmaceuticals, Inc. is recalling 182,850 Daytrana (methylphenidate) transdermal patches. The affected product is the 20 mg over 9 hours (2.2 mg/hr) prescription-only patch, manufactured for Noven Therapeutics, LLC. The specific lot number is 80431 with an expiration date of 08/17.
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 patches. The affected units were distributed nationwide.
Consumers who have this specific lot of Daytrana patches should stop using them and contact their healthcare provider or pharmacist for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- DAYTRANA (METHYLPHENIDATE)
- Brand
- DAYTRANA
- Manufacturer
- Noven Pharmaceuticals, Inc.
- Affected units
- 182,850
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: 80431 Exp. 08/17
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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