NDC 47335-361
decitabine 50 mg per 10 mL kit
On the label: Caraco Pharmaceutical Laboratories, Ltd..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | Halol, India | Makes it and tests it | Serious problems, FDA actionJun 13, 2025 · 12 inspections, 5 with FDA action |
Recalls
- Jul 2, 2024 · Class II · Sun Pharmaceutical Industries Inc
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Lots: HAD2964A, Exp 7/31/2024
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Decitabine: every company that makes it
- Form
- kit
- Strength
- 50 mg per 10 mL
- Approval
- NDA NDA205582
- On the market since
- Jan 24, 2014
- Package NDCs
47335-361-4147335-362-40- Official label
- DailyMed (National Library of Medicine), updated Jul 23, 2020
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