# FDA recall D-312-2013

> **Noven Pharmaceuticals, Inc.** · Class II · drug recall initiated 2013-01-31.

## Product

Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5552-3.

## Reason for recall

Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.

## Distribution

Nationwide and Puerto Rico.

## Key facts

- **Recall number:** D-312-2013
- **Recalling firm:** Noven Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-01-31
- **Report date:** 2013-05-08
- **Termination date:** 2016-12-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Miami, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-312-2013

## Citation

> AI Analytics. FDA recall D-312-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-312-2013. Source: US FDA. Licensed CC0.

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