EEMT — Class II drug recall D-0378-2019
Terminated recall by Syntho Pharmaceuticals, Inc., reported 2019-01-23, distributed nationwide. CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
| Recall number | D-0378-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Syntho Pharmaceuticals, Inc., Farmingdale, NY, United States |
| Recall initiated | 2017-04-17 |
| Classified | 2019-01-16 |
| Reported by FDA | 2019-01-23 |
| Terminated | 2020-03-27 |
| Distributed | Nationwide (US) |
| Quantity | 5,000 bottles |
| Reason classes | potency, cgmp |
| NDC | 15310-0010-01 |
| Lot numbers | 05/18, S16E02 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0378-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.