The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1413-2012·Announced 2012-07-18

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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.
Category
Drug — Prescription Transdermal Patch
Hazard
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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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