FDA Drug recall D-0377-2019
EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmace…
- FDA Drug
- Class II
- terminated
- Published 2019-01-23
On 2019-01-23 the FDA classified a Class II recall of EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmace… by Syntho Pharmaceuticals, citing CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0377-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-17 |
| Published | 2019-01-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Syntho Pharmaceuticals |
| Distribution | US |
Product
EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-020-01
Reason
CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
Identifiers
| code_info | Lot #: S16E01, Exp 05/18 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0377-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.