Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Dhar, India | Makes it and packages it | Problems found, fixed voluntarilySep 27, 2024 · 4 inspections |
Recalls
- Jul 21, 2020 · Class II · Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Lots: Lot #s: L900017, L900070, Exp. 12/31/2020; L900589, Exp. 03/31/2021; L901085, Exp. 04/30/2021; L901008, Exp. 06/30/2021; L901641, L901735, Exp.10/31/2021. - May 16, 2017 · Class I · Lupin Limited (Unit 1)
Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.
Lots: Batch Number L600518; 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
- Ethinyl Estradiol and Norethindrone: every company that makes it
- Form
- kit
- Strength
- 1 mg / 0.02 mg
- Approval
- ANDA ANDA206287
- On the market since
- Mar 31, 2020
- Package NDCs
68180-911-73- Official label
- DailyMed (National Library of Medicine), updated Dec 5, 2025
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