NDC 70710-1688
Fulvestrant 50 mg per 1 mL injection, solution
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 voluntarilyMay 5, 2026 · 2 inspections |
Recalls
- Jul 15, 2022 · Class II · Zydus Pharmaceuticals (USA) Inc
Failed Impurities/Degradation Specifications
Lots: Lot # B200076; Exp 31 JAN 2024
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Fulvestrant: every company that makes it
- Form
- injection, solution, intramuscular
- Strength
- 50 mg per 1 mL
- Approval
- ANDA ANDA215234
- On the market since
- Dec 14, 2021
- Package NDCs
70710-1688-270710-1688-8- Official label
- DailyMed (National Library of Medicine), updated Aug 20, 2024
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