Noven Recalls Daytrana Methylphenidate Patches Due to Defective Delivery System
Noven Pharmaceuticals is recalling Daytrana (methylphenidate) transdermal patches because the delivery system is miscalibrated or defective, potentially affecting drug delivery.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, an FDA Class II recall is assigned a severity score of 4 (Severe), as it indicates a potential for temporary or medically reversible adverse health consequences.
Plain-English summary
Noven Pharmaceuticals, Inc. is recalling 185,160 patches of Daytrana (methylphenidate) Transdermal System, 20 mg, Lot # 53995. The product is a prescription-only medication manufactured for Shire US Inc. The recall covers patches distributed nationwide and in Puerto Rico.
The recall was initiated because the product's delivery system is miscalibrated or defective. Specifically, the patches exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value. This defect may affect the reliability of the drug delivery system.
Consumers with this specific lot of Daytrana patches should stop using them and contact their healthcare provider or pharmacist for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- DAYTRANA (METHYLPHENIDATE)
- Brand
- DAYTRANA
- Manufacturer
- Noven Pharmaceuticals, Inc.
- Affected units
- 185,160
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 # 53995
Distribution
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