# FDA recall D-0666-2017

> **Medisca, Inc.** · Class II · drug recall initiated 2017-04-03.

## Product

ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04)  and b) 100 g (NDC 38779-2261-05) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY Product Code 2261

## Reason for recall

cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection

## Distribution

Nationwide, Australia, Bahamas, Italy, Singapore, Thailand, United Kingdom

## Key facts

- **Recall number:** D-0666-2017
- **Recalling firm:** Medisca, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-04-03
- **Report date:** 2017-04-19
- **Termination date:** 2019-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plattsburgh, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0666-2017

## Citation

> AI Analytics. FDA recall D-0666-2017. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0666-2017. Source: US FDA. Licensed CC0.

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