# FDA recall D-1413-2012

> **Noven Pharmaceuticals, Inc.** · Class II · drug recall initiated 2012-03-22.

## Product

Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68968-5554-01) packaged in 3-count patches per box (NDC 68968-5554-3) , Rx only, Manufactured  for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33816.08/04/12.

## Reason for recall

Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1413-2012
- **Recalling firm:** Noven Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-03-22
- **Report date:** 2012-07-18
- **Termination date:** 2014-05-09

- **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-1413-2012

## Citation

> AI Analytics. FDA recall D-1413-2012. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-1413-2012. Source: US FDA. Licensed CC0.

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