Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Dhar, India | Makes it, makes the active ingredient and packages it | Problems found, fixed voluntarilySep 27, 2024 · 4 inspections |
Recalls
- Dec 26, 2019 · Class II · Lupin Pharmaceuticals Inc.
Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
Lots: Lot: H801227, Exp. Date January 2020
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Ethinyl Estradiol and Norethindrone: every company that makes it
- Form
- kit
- Strength
- 1.5 mg / 0.03 mg
- Approval
- ANDA ANDA201585
- On the market since
- Nov 7, 2019
- Package NDCs
68180-866-73- Official label
- DailyMed (National Library of Medicine), updated May 8, 2025
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