# FDA recall D-0792-2017

> **Fagron, Inc** · Class II · drug recall initiated 2017-04-06.

## Product

Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-0445-1), b)  5 G bottle (NDC 51552-0445-2), c) 25 G bottle (NDC: 51552-0445-4), d)  100 G bottle (NDC: 51552-0445-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967      Also packaged as: Estrone USP, For Prescription Compounding, packaged in a) 1 G bottle (NDC 52372-9494-01), b) 5 G bottle (NDC 52372-9494-05), c) 25 G bottle (NDC 52372-9494-03), d) 100 G bottle ( NDC 52372-9494-02), Rx only, Distributed by FREEDOM 801 W. New Orleans St. Broken Arrow, OK 74011 Tel. (877) 839-8547

## Reason for recall

cGMP Deviations: lack of quality assurance at the API manufacturer.

## Distribution

Nationwide in US and PR and Australia

## Key facts

- **Recall number:** D-0792-2017
- **Recalling firm:** Fagron, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-04-06
- **Report date:** 2017-05-31
- **Termination date:** 2019-07-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0792-2017

## Citation

> AI Analytics. FDA recall D-0792-2017. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0792-2017. Source: US FDA. Licensed CC0.

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