# FDA recall D-1209-2018

> **Noven Pharmaceuticals, Inc.** · Class II · drug recall initiated 2018-09-07.

## Product

Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6625-8

## Reason for recall

Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1209-2018
- **Recalling firm:** Noven Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-09-07
- **Report date:** 2018-10-03
- **Termination date:** 2020-09-09

- **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-1209-2018

## Citation

> AI Analytics. FDA recall D-1209-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1209-2018. Source: US FDA. Licensed CC0.

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