The Recall Desk
ModerateFDA (Drugs)·D-1608-2014·Announced 2014-10-01

Noven Recalls Daytrana Patches Due to Defective Delivery System

Noven Pharmaceuticals is recalling 160,800 Daytrana patches because the adhesive release liner may be difficult to remove.

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

Plain-English summary

Noven Pharmaceuticals, Inc. is recalling 160,800 Daytrana (methylphenidate) transdermal patches. The recall involves Lot # 71165 with an expiration date of 12/14. The product is 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 should stop using the affected patches and contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
DAYTRANA (METHYLPHENIDATE)
Brand
DAYTRANA
Manufacturer
Noven Pharmaceuticals, Inc.
Category
Drug — Transdermal Patch
Hazard
Affected units
160,800

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 # 71165
  • Exp. 12/14

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · DAYTRANA

Same manufacturer · Noven Pharmaceuticals, Inc.

See all →

Same hazard · defective delivery system

See all →