# FDA recall D-0863-2018

> **Noven Pharmaceuticals, Inc.** · Class II · drug recall initiated 2018-05-04.

## Product

Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (NDC 68968-6637-1), packaged in 8 pouches per box (NDC 68968-6637-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Florida 33186.

## Reason for recall

Defective Delivery System: no longer meets the specification for 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 in the USA.

## Key facts

- **Recall number:** D-0863-2018
- **Recalling firm:** Noven Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-05-04
- **Report date:** 2018-05-16
- **Termination date:** 2020-06-04

- **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-0863-2018

## Citation

> AI Analytics. FDA recall D-0863-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0863-2018. Source: US FDA. Licensed CC0.

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