Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi USA, LLC | Melrose Park, IL, United States | Makes it and tests it | Problems found, fixed voluntarilyAug 24, 2023 · 13 inspections, 2 with FDA action |
Recalls
- Nov 8, 2013 · Class III · Fresenius Kabi USA, LLC
Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
Lots: Lot # 871ZA00201, Exp 11/13 Lot # 871ZA00301, Exp 11/13 Lot # 871ZA00302, Exp 11/13 Lot # 871ZA00401, Exp 11/13 Lot # 871ZA00402, Exp 11/13 Lot # 872ZA00101, Exp 12/13 Lot # 872ZA00201, Exp 12/13 Lot # 872ZA00301, Exp 12/13 Lot # 872ZA00401, Exp 12/13 Lot # 872ZA00501, Exp 12/13
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Paclitaxel: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 6 mg per 1 mL
- Approval
- ANDA ANDA077574
- On the market since
- Mar 20, 2009
- Package NDCs
63323-763-0563323-763-1663323-763-50- Official label
- DailyMed (National Library of Medicine), updated Sep 19, 2024
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