# FDA recall D-0891-2017

> **Qualgen** · Class II · drug recall initiated 2017-04-19.

## Product

Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-020-01

## Reason for recall

CGMP deviations- Lack of Quality Assurance

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-0891-2017
- **Recalling firm:** Qualgen
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-04-19
- **Report date:** 2017-06-14
- **Termination date:** 2021-09-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Edmond, OK, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0891-2017

## Citation

> AI Analytics. FDA recall D-0891-2017. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0891-2017. Source: US FDA. Licensed CC0.

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