The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1439-2016·Announced 2016-07-20

Noven Recalls Daytrana Patches Due to Defective Delivery System

Noven Pharmaceuticals is recalling 2,088 boxes of Daytrana transdermal patches because the release liner may be difficult to remove.

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 2/5 (Moderate).

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 hazard involves a mechanical defect in the delivery system that may impede proper use, without reported injuries or fatalities.

Plain-English summary

Noven Pharmaceuticals, Inc. is recalling 2,088 boxes of Daytrana (methylphenidate) transdermal patches, 20 mg over 9 hours. The affected product is Lot # 77140, with an expiration date of 05/16, and was distributed nationwide.

The recall was initiated due to out-of-specification results for the mechanical peel force and z-statistic value. These defects relate to the ability of patients and caregivers to remove the release liner from the patch adhesive prior to administration.

Consumers with this specific lot should stop using the product and contact their healthcare provider or pharmacist for guidance.

The recalled product

Product
DAYTRANA (METHYLPHENIDATE)
Brand
DAYTRANA
Manufacturer
Noven Pharmaceuticals, Inc.
Category
Drug — Transdermal Patch
Hazard
Affected units
2,088

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 (2)

  • Lot # 77140
  • Exp 05/16

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 →

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