The Recall Desk
ModerateFDA (Drugs)·D-1440-2016·Announced 2016-07-20

Noven Recalls Daytrana Patches Due to Defective Delivery System

Noven Pharmaceuticals is recalling specific lots of Daytrana transdermal patches because the 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 defect involves a mechanical issue with the delivery system (liner removal) rather than a direct chemical contamination or reported injury, fitting the Moderate criteria for low-risk or precautionary issues.

Plain-English summary

Noven Pharmaceuticals, Inc. is recalling 12,285 boxes of Daytrana (methylphenidate) transdermal patches, 30 mg over 9 hours. The affected products are distributed nationwide and include lot numbers 77379, 77380 (expiration 05/16), and 76944 (expiration 03/16).

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 check their medication for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, they should stop using it and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
DAYTRANA (METHYLPHENIDATE)
Brand
DAYTRANA
Manufacturer
Noven Pharmaceuticals, Inc.
Category
Drug — Transdermal Patch
Hazard
Affected units
12,285

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 (5)

  • Lot #s: 77379
  • 77380
  • Exp 05/16
  • 76944
  • Exp 03/16

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 →

Related recalls

Same brand · DAYTRANA

Same manufacturer · Noven Pharmaceuticals, Inc.

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Same hazard · delivery system defect

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