# FDA recall D-0386-2016

> **Qualgen** · Class II · drug recall initiated 2015-10-09.

## Product

Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg (NDC 69761-006-01),10 mg (NDC 69761-010-01),12.5 mg (NDC 69761-012-01), 15 mg (NDC 69761-015-01),18 mg (NDC 69761-018-01),20 mg (NDC 69761-020-01), 22 mg (NDC 69761-022-01), 25 mg (NDC 69761-025-01), Rx only, Compounded by Qualgen, Edmond, Oklahoma 73013

## Reason for recall

Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0386-2016
- **Recalling firm:** Qualgen
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-10-09
- **Report date:** 2015-12-02
- **Termination date:** 2017-03-30

- **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-0386-2016

## Citation

> AI Analytics. FDA recall D-0386-2016. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0386-2016. Source: US FDA. Licensed CC0.

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