# FDA recall D-0079-2018

> **Fagron, Inc** · Class II · drug recall initiated 2017-10-25.

## 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) and 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

## Reason for recall

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

## Distribution

Nationwide in USA

## Key facts

- **Recall number:** D-0079-2018
- **Recalling firm:** Fagron, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-10-25
- **Report date:** 2017-11-22
- **Termination date:** 2018-05-11

- **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-0079-2018

## Citation

> AI Analytics. FDA recall D-0079-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/D-0079-2018. Source: US FDA. Licensed CC0.

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