# FDA recall D-1172-2014

> **Noven Pharmaceuticals, Inc.** · Class II · drug recall initiated 2014-02-13.

## Product

Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3mg/hr), 1patch 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 68968-5555-3.

## 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.

## Key facts

- **Recall number:** D-1172-2014
- **Recalling firm:** Noven Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-02-13
- **Report date:** 2014-03-26
- **Termination date:** 2019-03-19

- **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-1172-2014

## Citation

> AI Analytics. FDA recall D-1172-2014. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-1172-2014. Source: US FDA. Licensed CC0.

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