# FDA recall D-0337-2021

> **Noven Pharmaceuticals Inc** · Class II · drug recall initiated 2021-04-16.

## Product

Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186  Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-3437-8

## Reason for recall

Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0337-2021
- **Recalling firm:** Noven Pharmaceuticals Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-04-16
- **Report date:** 2021-04-28
- **Termination date:** 2024-10-11

- **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-0337-2021

## Citation

> AI Analytics. FDA recall D-0337-2021. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/D-0337-2021. Source: US FDA. Licensed CC0.

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