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 peel force specifications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a defective delivery system with out-of-specification mechanical peel force, which poses a risk of harm (inadequate drug delivery or device failure) without reported illnesses or injuries in the source text.
Plain-English summary
Noven Pharmaceuticals, Inc. is recalling 357,420 patches of Daytrana (methylphenidate transdermal system), 30 mg over 9 hours. The affected products are packaged in 30-count boxes and were distributed nationwide within the US.
The recall was initiated due to a defective delivery system. Specifically, the products produced out-of-specification (OOS) results for the mechanical peel force (MPF) and/or the z-statistic values. The affected lot numbers are 77306 (Exp. 05/2016), 77595 (Exp. 07/2016), and 78069 (Exp. 08/2016).
Consumers who have these specific lot numbers should stop using the product and contact their healthcare provider or pharmacist for guidance. 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
- 357,420
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 (5)
- Lot #: 77306
- Exp.05/2016
- 77595 Exp. 07/2016
- 78069
- Exp.08/2016.
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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