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
- Nov 8, 2012 · Class I · Hospira Inc.
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
Lots: lots Z011711AA (Hospira label) and Z011711AB (Novaplus label), Exp. 08/2013 - 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… - Jun 27, 2012 · Class II · Hospira Inc.
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are beig 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 Y061711AA, exp FEB 2013 and Y061711AB, exp FEB 2013 rest of world lots being recalled: list M1685A001, lots numbers Y151686AB, exp MAY 2013 and Y131686AA, exp MAR 2013; list M1723A001, lot number Y121686AF, exp SEP 2013; list M1686ADE1, lot numbers Y121686AA, exp SEP 2013 and Y…
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
61703-360-18- Official label
- DailyMed (National Library of Medicine), updated Aug 21, 2024
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