NDC 70710-1195
Estradiol 0.1 mg per 1 d patch, extended release
On the label: Zydus Pharmaceuticals (USA) Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Lifesciences Limited | Ahmedabad, India | Makes it and tests it | Problems found, fixed voluntarilyAug 5, 2022 · 10 inspections, 3 with FDA action |
Recalls
- May 16, 2024 · Class III · Zydus Pharmaceuticals (USA) Inc
Failed Impurities/Degradation Specifications.
Lots: Lot #: M310493, Exp. Date 01/2025; M308397, Exp. Date 11/2024; M305337, Exp. Date 10/2024; M400155, Exp. Date 06/2025; M314660, Exp. Date 05/2025 - May 16, 2024 · Class III · Zydus Pharmaceuticals (USA) Inc
Failed Impurities/Degradation Specifications.
Lots: Lot #: M311202, Exp. Date 2/25; M311201, Exp. Date 1/25
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Estradiol: every company that makes it
- Form
- patch, extended release, transdermal
- Strength
- 0.1 mg per 1 d
- Approval
- ANDA ANDA206241
- On the market since
- Apr 13, 2023
- Package NDCs
70710-1195-170710-1195-8- Official label
- DailyMed (National Library of Medicine), updated Mar 15, 2024
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