The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0428-2017·Announced 2017-01-18

Noven Recalls Daytrana Patches Due to Defective Delivery System

Noven Pharmaceuticals is recalling 1,068,600 Daytrana transdermal patches nationwide because the delivery system failed mechanical peel force specifications.

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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), as they represent a reasonable probability of temporary or medically reversible adverse health consequences.

Plain-English summary

Noven Pharmaceuticals, Inc. is recalling 1,068,600 units of Daytrana (methylphenidate) transdermal patches, 10 mg over 9 hours. The affected product is distributed nationwide within the United States. The recall involves specific lots with expiration dates ranging from July 2016 to March 2017.

The recall was initiated due to a defective delivery system. Specifically, the product produced out-of-specification results for the mechanical peel force and/or z-statistic values. These technical failures indicate that the patch may not deliver the medication as intended.

Consumers who have these specific lots of Daytrana should stop using the product and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating a reasonable probability of temporary or medically reversible adverse health consequences.

The recalled product

Product
DAYTRANA (METHYLPHENIDATE)
Brand
DAYTRANA
Manufacturer
Noven Pharmaceuticals, Inc.
Category
Drug — Transdermal Patch
Hazard
Affected units
1,068,600

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 (8)

  • Lot #: 77545
  • Exp.07/2016
  • 78035
  • Exp. 08/2016
  • 78367
  • Exp. 10/2016
  • 79919
  • Exp. 03/2017.

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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