# FDA recall D-0628-2020

> **Spectrum Laboratory Products** · Class II · drug recall initiated 2019-12-11.

## Product

Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP, CAS 50-27-1, packaged in a) 1 G glass bottles, b) 5 G glass bottles, c) 25 G glass bottles, d) 100 G glass bottles, e) 500 G glass bottles, and f) 1 KG plastic bottles, Rx Only, Spectrum Chemical Mfg Corp., Gardena, CA 90248.

## Reason for recall

Subpotent Drug: Supplier indicated assay results did not meet specifications.

## Distribution

Nationwide in the USA and Canada

## Key facts

- **Recall number:** D-0628-2020
- **Recalling firm:** Spectrum Laboratory Products
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-12-11
- **Report date:** 2020-01-01
- **Termination date:** 2023-08-17

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0628-2020

## Citation

> AI Analytics. FDA recall D-0628-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-0628-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*