# FDA recall D-0008-2016

> **Noven Pharmaceuticals, Inc.** · Class II · drug recall initiated 2015-07-27.

## Product

Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufactured for: Noven Therapies, LLC., Miami, FL 33186, by: Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC: 68968-5555-3

## Reason for recall

Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.

## Distribution

US Nationwide

## Key facts

- **Recall number:** D-0008-2016
- **Recalling firm:** Noven Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-07-27
- **Report date:** 2015-10-14
- **Termination date:** 2019-03-20

- **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-0008-2016

## Citation

> AI Analytics. FDA recall D-0008-2016. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0008-2016. Source: US FDA. Licensed CC0.

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