NDC 43598-610
Docetaxel 80 mg per 4 mL injection, solution
On the label: Dr. Reddy's Laboratories Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Dr.reddy's Laboratories Limited | Visakhapatnam, India | Makes it and tests it | Problems found, fixed voluntarilyMay 17, 2024 · 9 inspections, 2 with FDA action |
Recalls
- Jan 9, 2017 · Class II · Dr. Reddy's Laboratories, Inc.
Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is removed when the cap is flipped off.
Lots: Lot #: H7044, Exp 05/19
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Docetaxel: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 80 mg per 4 mL
- Approval
- ANDA ANDA204193
- On the market since
- Aug 22, 2017
- Package NDCs
43598-610-40- Official label
- DailyMed (National Library of Medicine), updated Jun 23, 2020
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