NDC 15310-020
Eemths 1.25 mg / 0.625 mg tablet, coated
On the label: Creekwood Pharmaceutical, Inc,.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Syntho Pharmaceuticals Inc. | Farmingdale, NY, United States | Makes it and packages it | Serious problems, FDA actionSep 3, 2019 · 10 inspections, 8 with FDA action |
Recalls
- Apr 17, 2017 · Class II · Syntho Pharmaceuticals, Inc.
CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
Lots: Lot #: S16E01, Exp 05/18
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Estrogens, Esterified and Methyltestosterone: every company that makes it
- Form
- tablet, coated
- Strength
- 1.25 mg / 0.625 mg
- Approval
- unapproved drug other
- On the market since
- Sep 1, 2011
- Package NDCs
15310-020-01- Official label
- DailyMed (National Library of Medicine), updated Jan 22, 2020
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