# FDA recall D-1172-2017

> **Noven Pharmaceuticals, Inc.** · Class II · drug recall initiated 2017-08-30.

## Product

Daytrana (methylphenidate transdermal system) Delivers 15 mg over 9 hours (1.6 mg/hr) Rx Only Contains: 30 Patches  Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5553-3

## Reason for recall

Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-1172-2017
- **Recalling firm:** Noven Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-08-30
- **Report date:** 2017-09-27
- **Termination date:** 2020-01-24

- **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-1172-2017

## Citation

> AI Analytics. FDA recall D-1172-2017. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-1172-2017. Source: US FDA. Licensed CC0.

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