Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hospira Australia Pty Ltd | Mulgrave, Australia | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilySep 2, 2022 · 6 inspections, 1 with FDA action |
Recalls
- Jun 27, 2012 · Class II · Hospira Inc.
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Lots: lot numbers Y096865AA, exp AUG 2013; Y106865AA, exp AUG 2013; Y116865AA, exp AUG 2013; Y126865AA, exp SEP 2013; Y136865AA, exp SEP 2013; Y146865AA, exp SEP 2013; Y156865AA, exp OCT 2013; Y166865AA, exp NOV 2013; Y176865AA, exp NOV 2013; and Y186865AA, exp DEC 2013
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 ANDA076131
- On the market since
- Apr 8, 2025
- Package NDCs
61703-015-04- Official label
- DailyMed (National Library of Medicine), updated Jul 2, 2026
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