NDC 47335-050
Doxorubicin Hydrochloride 2 mg per 1 mL injectable, liposomal
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
- Jan 16, 2018 · Class II · Sun Pharmaceutical Industries, Inc.
Lack Of Assurance Of Sterility
Lots: Lot # JKS0403A Exp 02/2019
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Doxorubicin: every company that makes it
- Form
- injectable, liposomal, intravenous
- Strength
- 2 mg per 1 mL
- Approval
- ANDA ANDA203263
- On the market since
- Feb 5, 2013
- Package NDCs
47335-050-40- Official label
- DailyMed (National Library of Medicine), updated Apr 6, 2026
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