# FDA recall D-0627-2018

> **Noven Pharmaceuticals, Inc.** · Class II · drug recall initiated 2018-04-09.

## Product

Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches Rx Only NDC 68968-5552-3 Manufactured for Noven Therapeutics, LLC., Miami, FL 33186 by Noven Pharmaceuticals, Inc. Miami, FL 33186 1-877-567-7857

## Reason for recall

Defective Delivery System: Out of specification for adhesive transfer.

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-0627-2018
- **Recalling firm:** Noven Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-04-09
- **Report date:** 2018-04-25
- **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-0627-2018

## Citation

> AI Analytics. FDA recall D-0627-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0627-2018. Source: US FDA. Licensed CC0.

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