# FDA recall D-0919-2017

> **American Pharmaceutical Ingredients LLC** · Class II · drug recall initiated 2017-04-17.

## Product

ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8049-4), For Prescription Compounding, RX Only, Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC, 6650 Highland Road, Waterford, MI 48327

## Reason for recall

cGMP Deviations; lack of quality assurance.

## Distribution

NY, GA, NV, CA, KY, TX

## Key facts

- **Recall number:** D-0919-2017
- **Recalling firm:** American Pharmaceutical Ingredients LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-04-17
- **Report date:** 2017-06-21
- **Termination date:** 2018-05-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waterford, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0919-2017

## Citation

> AI Analytics. FDA recall D-0919-2017. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-0919-2017. Source: US FDA. Licensed CC0.

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