NDC 68462-317
Fulvestrant 50 mg per 1 mL injection
On the label: Glenmark Pharmaceuticals Inc., USA.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Glenmark Pharmaceuticals Inc., USA | Monroe, NC, United States | Makes it | Problems found, fixed voluntarilyJun 17, 2025 · 2 inspections, 1 with FDA action |
| PCI San Diego, Inc. | San Diego, CA, United States | Makes it | Problems found, fixed voluntarilyMay 9, 2025 · 11 inspections |
Recalls
- Aug 27, 2021 · Class II · Glenmark Pharmaceuticals Inc., USA
Lack of Assurance of Sterility
Lots: Lots: 30200014 Exp. 04/30/2022; 30200015 Exp. 05/31/2022; 30200015 Exp. 05/31/2022; 30200016 Exp. 05/31/2022; 30200036 Exp. 09/30/2022; 30200038 Exp. 09/30/2022; 30200039 Exp. 09/30/2022; 30200040 Exp. 09/30/2022; 30210001 Exp. 12/31/2022; 30210002 Exp. 12/31/2022; 30210003 Exp. 01/31/2023; 3021000…
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, intramuscular
- Strength
- 50 mg per 1 mL
- Approval
- ANDA ANDA207754
- On the market since
- Aug 22, 2019
- Package NDCs
68462-317-3268462-317-40- Official label
- DailyMed (National Library of Medicine), updated Feb 27, 2026
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