The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1653-2012·Announced 2012-08-29

Noven Recalls Daytrana Patches Due to Defective Delivery System

Noven Pharmaceuticals is recalling 177,900 Daytrana (methylphenidate) patches because the delivery system may be miscalibrated or defective, potentially affecting the removal of the release liner.

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 as a Class II recall, which corresponds to a Severe severity score under the rubric, as it involves a defect that could cause temporary or medically reversible health consequences.

Plain-English summary

Noven Pharmaceuticals, Inc. is recalling 177,900 Daytrana (methylphenidate) transdermal system patches. The affected product is the 20 mg over 9 hours (2.2 mg/hr) patch, packaged in 30-count boxes. The specific lot is # 55302 with an expiration date of 12/12. The product was distributed nationwide and in Puerto Rico.

The recall was initiated due to out-of-specification results 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 FDA has classified this as a Class II recall.

Consumers should stop using the affected patches and contact their healthcare provider or pharmacist for further instructions. The recall is limited to the specific lot number and expiration date listed above.

The recalled product

Product
DAYTRANA (METHYLPHENIDATE)
Brand
DAYTRANA
Manufacturer
Noven Pharmaceuticals, Inc.
Category
Drug — Transdermal Patch
Hazard
Affected units
177,900

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 # 55302
  • Exp 12/12

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 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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