# FDA recall D-0652-2020

> **Asclemed USA Inc. dba Enovachem Pharmaceuticals** · Class II · drug recall initiated 2019-12-09.

## Product

Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38

## Reason for recall

Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.

## Distribution

Product was distributed to 6 physician's offices within the state of California.

## Key facts

- **Recall number:** D-0652-2020
- **Recalling firm:** Asclemed USA Inc. dba Enovachem Pharmaceuticals
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-12-09
- **Report date:** 2020-01-15
- **Termination date:** 2023-08-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Torrance, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0652-2020

## Citation

> AI Analytics. FDA recall D-0652-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0652-2020. Source: US FDA. Licensed CC0.

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