Noven Recalls Daytrana Patches Due to Defective Delivery System
Noven Pharmaceuticals is recalling 321,900 Daytrana patches because the delivery system no longer meets 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, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The defect is a manufacturing specification failure without reported injuries.
Plain-English summary
Noven Pharmaceuticals, Inc. is recalling 321,900 units of Daytrana (methylphenidate transdermal system) 10 mg patches. The affected product is Lot 80433 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.
The recall covers products distributed nationwide. Daytrana is a prescription-only medication manufactured for Noven Therapeutics, LLC. The specific defect involves the delivery system of the transdermal patch.
Consumers and healthcare providers should stop using the affected lot and contact their healthcare provider or pharmacist for further instructions. Noven Pharmaceuticals is the recalling firm responsible for this action.
The recalled product
- Product
- DAYTRANA (METHYLPHENIDATE)
- Brand
- DAYTRANA
- Manufacturer
- Noven Pharmaceuticals, Inc.
- Category
- Drug — Transdermal Patch
- Affected units
- 321,900
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: 80433 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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