# FDA recall D-0378-2019

> **Syntho Pharmaceuticals, Inc.** · Class II · drug recall initiated 2017-04-17.

## Product

EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-010-01

## Reason for recall

CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.

## Distribution

Product was sold to the firm's sole distributor who further distributed the product throughout the United States.

## Key facts

- **Recall number:** D-0378-2019
- **Recalling firm:** Syntho Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-04-17
- **Report date:** 2019-01-23
- **Termination date:** 2020-03-27

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0378-2019

## Citation

> AI Analytics. FDA recall D-0378-2019. Retrieved 2026-06-22 from https://api.ai-analytics.org/recall/D-0378-2019. Source: US FDA. Licensed CC0.

---

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