Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Glenmark Pharmaceuticals Limited | Goa, India | Makes it and tests it | Problems found, fixed voluntarilyJun 30, 2026 · 7 inspections, 1 with FDA action |
Recalls
- May 27, 2026 · Class II · Glenmark Pharmaceuticals Inc., USA
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Lots: Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027
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 / 0.035 mg
- Approval
- ANDA ANDA091634
- On the market since
- Jan 19, 2012
- Package NDCs
68462-394-2968462-394-84- Official label
- DailyMed (National Library of Medicine), updated Jan 31, 2026
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