# FDA recall D-0294-2021

> **Noven Pharmaceuticals Inc** · Class II · drug recall initiated 2021-02-19.

## Product

Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches in in a foil-sealed polypropylene tray,  packed in a paper carton, Rx only, 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: Out of specification for mechanical peel.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0294-2021
- **Recalling firm:** Noven Pharmaceuticals Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-02-19
- **Report date:** 2021-03-10
- **Termination date:** 2024-07-05

- **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-0294-2021

## Citation

> AI Analytics. FDA recall D-0294-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0294-2021. Source: US FDA. Licensed CC0.

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