Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Aspen Oss B.V. | Oss, Netherlands | Makes the active ingredient | Problems found, fixed voluntarilyNov 24, 2022 · 3 inspections |
| Aspen Oss B.V. | Oss, Netherlands | Makes the active ingredient | Problems found, fixed voluntarilyNov 24, 2022 · 3 inspections |
Recalls
- Sep 18, 2018 · Class III · Xiromed LLC
Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
Lots: Lots: LF11838A Expiry May 2020; LF12107A, LF12106A, Expiry June 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 Levonorgestrel: every company that makes it
- Form
- kit
- Strength
- 0.03 mg / 0.15 mg
- Approval
- ANDA ANDA079102
- On the market since
- Sep 1, 2022
- Package NDCs
70700-116-85- Official label
- DailyMed (National Library of Medicine), updated Feb 10, 2023
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