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
- Jun 23, 2023 · Class I · Lupin Pharmaceuticals Inc.
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
Lots: Lot #: L200183, Exp 1/2024; L201560, Exp 9/2024 - Nov 19, 2021 · Class III · Lupin Pharmaceuticals Inc.
Subpotent Drug
Lots: Lot #: L000784 and L000785, Exp. Date May 2022
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Drospirenone and Ethinyl Estradiol and Levomefolic Acid: every company that makes it
- Form
- kit
- Strength
- 4 ingredients
- Approval
- ANDA ANDA205948
- On the market since
- Nov 20, 2020
- Package NDCs
68180-904-7368180-905-7468180-910-74- Official label
- DailyMed (National Library of Medicine), updated Dec 29, 2025
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