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
- Jul 2, 2012 · Class III · Hospira Inc.
Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.
Lots: 5 mL vial - NDC 61703-339-18 (Hospira label), lot number Y031654AB, expiration APR2013; NDC 61703-360-18 (Novoplus label), lot number Y031654AA, expiration APR2013; 45 mL vial - NDC 61703-339-50 (Hospira label), lot numbers Y041711AA, expiration DEC 2012 and Y061711AB, expiration FEB 2013; NDC 61…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Carboplatin: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 10 mg per 1 mL
- Approval
- ANDA ANDA076517
- On the market since
- May 23, 2022
- Package NDCs
61703-262-05- Official label
- DailyMed (National Library of Medicine), updated Aug 21, 2024
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