NDC 68462-496
deferasirox 500 mg tablet, for suspension
On the label: Glenmark Pharmaceuticals Inc., USA.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Glenmark Pharmaceuticals Limited | Dhar, India | Makes it and tests it | Serious problems, FDA actionFeb 14, 2025 · 8 inspections, 1 with FDA action |
Recalls
- Oct 20, 2023 · Class II · Glenmark Pharmaceuticals Inc., USA
Failed Dissolution Specifications
Lots: Lot #: 17220063, Exp 12/2023; 17220396, 17220397, Exp 01/2024; 17220965, Exp 04/2024; 17221187, 17221523, Exp 07/2024; 17221793, 17221794, 17221801, Exp 08/2024
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Deferasirox: every company that makes it
- Form
- tablet, for suspension, oral
- Strength
- 500 mg
- Approval
- ANDA ANDA209433
- On the market since
- Jan 6, 2020
- Package NDCs
68462-496-3068462-496-90- Official label
- DailyMed (National Library of Medicine), updated Oct 9, 2026
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