# FDA recall D-0923-2017

> **Noven Pharmaceuticals, Inc.** · Class III · drug recall initiated 2017-04-27.

## Product

Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida 33186.  NDC: 68968-6610-8

## Reason for recall

Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.

## Distribution

Nationwide within US

## Key facts

- **Recall number:** D-0923-2017
- **Recalling firm:** Noven Pharmaceuticals, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-04-27
- **Report date:** 2017-07-05
- **Termination date:** 2019-03-11

- **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-0923-2017

## Citation

> AI Analytics. FDA recall D-0923-2017. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-0923-2017. Source: US FDA. Licensed CC0.

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