NDC 0955-1022
Docetaxel 160 mg per 8 mL injection, solution, concentrate
On the label: Sanofi-Aventis U.S. LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sanofi Winthrop Industrie | Vitry sur-Seine, France | Makes the active ingredient and tests it | Problems found, fixed voluntarilyOct 4, 2024 · 6 inspections |
| Sanofi-Aventis Deutschland GmbH | Frankfurt am Main, Germany | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyMar 25, 2022 · 10 inspections, 1 with FDA action |
Recalls
- Apr 27, 2018 · Class II · Sanofi-Aventis U.S. LLC
Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
Lots: Lot #: 7F307A, 7F307C, Exp 01/2019
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Docetaxel: every company that makes it
- Form
- injection, solution, concentrate, intravenous
- Strength
- 160 mg per 8 mL
- Approval
- NDA authorized generic NDA020449
- On the market since
- Oct 23, 2016
- Package NDCs
0955-1022-08- Official label
- DailyMed (National Library of Medicine), updated Dec 6, 2024
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