The Recall Desk
ModerateFDA (Drugs)·D-1374-2012·Announced 2012-06-20

Noven Recalls Daytrana Patches Due to Defective Delivery System

Noven Pharmaceuticals is recalling 244,320 Daytrana patches because the delivery system is miscalibrated or defective, making it difficult to remove the release liner.

What this means for you

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, which typically involves a reasonable probability of temporary or medically reversible health consequences. The defect affects the ease of removing the liner, which is a functional issue rather than a direct contamination or dosage error, fitting the Moderate severity criteria for minor labeling or functional errors without reported serious injury.

Plain-English summary

Noven Pharmaceuticals, Inc. is recalling 244,320 Daytrana (methylphenidate) transdermal system patches. The affected product is the 15 mg over 9 hours (1.6 mg/hr) strength, packaged in 30-count boxes (NDC 54092-553-30). The recall covers Lot #43783 with an expiration date of 01/12.

The recall was initiated because the patches have miscalibrated and/or defective delivery systems. Specifically, the products failed to meet specifications for mechanical peel force and/or the z-statistic value. These defects relate to the patient's ability to remove the release liner from the patch adhesive prior to administration.

The affected patches were distributed nationwide and in Puerto Rico. Consumers should stop using the recalled patches and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch (NDC 54092-553-01), packaged in 30-count patches per box (NDC 54092-553-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087; by Noven Pharmaceuticals, Inc.,
Manufacturer
Noven Pharmaceuticals, Inc.
Category
Drug — Transdermal Patch
Hazard
Affected units
244,320

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 #: 43783
  • Exp 01/12

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

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Same manufacturer · Noven Pharmaceuticals, Inc.

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