# FDA recall D-0791-2017

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

## Product

Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2),  c) 25 G bottle (NDC: 51552-1392-3), d) 100 G bottle (NDC: 51552-1392-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967     Also packaged as: Estriol USP Micronized, For prescription compounding, packaged in a 100 G bottle (NDC 52372-9292-01),  Rx only, Distributed by FREEDOM, 801 W. New Orleans St. Broken Arrow, OK 74011

## 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-0791-2017
- **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-0791-2017

## Citation

> AI Analytics. FDA recall D-0791-2017. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0791-2017. Source: US FDA. Licensed CC0.

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