CLASS II Drug recall · Reported 26 Sep 2012 · FDA Enforcement Report
Carboplatin Injection, 10 mg/mL Multi-Dose Vial recalled by Hospira
Hospira is recalling Carboplatin Injection, 10 mg/mL Multi-Dose Vial, distributed nationwide in the US. The recall was initiated on 27 Jun 2012 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1679-2012
- FDA event ID
- 62459
- Recalling firm
- Hospira, Lake Forest, IL
- Brand
- Carboplatin
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jun 2012
- FDA classified
- 19 Sep 2012
- Reported
- 26 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 27 Jun 2012 | Recall initiated by company | |
| 19 Sep 2012 | Classified by FDA | +84 days |
| 26 Sep 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Carboplatin Injection, 10 mg/mL, 45 mL Multi-Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-50 (Hospira label), NDC 61703-360-50 (Novoplus label)
Where it was distributed
Nationwide, including Puerto Rico and Guam. Product was also distributed internationally to Australia, Belgium, Canada, France, Germany, Korea, Malaysia, New Zealand, Norway, Pakistan, Philippines, Portugal, Singapore, Sweden, Thailand and Vietnam
Questions about this recall
Is Carboplatin Injection, 10 mg/mL Multi-Dose Vial recalled?
Yes. Hospira recalled Carboplatin Injection, 10 mg/mL Multi-Dose Vial on 27 Jun 2012. The recall is Class II and its status is Terminated. Recall number D-1679-2012.
Why was it recalled?
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.
Which lots are affected?
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 Y151686AC, exp NOV 2013; list M1686AFR1, lot numbers Y121686AG, exp SEP 2013 and Y131686AB, exp SEP 2013; list M1714A001, lot number Y121686AC, exp SEP 2013; list M1686ANO3, lot number Y121686AE, exp SEP 2013; list M1686ASE2, lot number Y121686AB, exp SEP 2013
Where was it sold?
Nationwide, including Puerto Rico and Guam. Product was also distributed internationally to Australia, Belgium, Canada, France, Germany, Korea, Malaysia, New Zealand, Norway, Pakistan, Philippines, Portugal, Singapore, Sweden, Thailand and Vietnam
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Drug | CLASS II | Fentanyl Citrate Injection, USP, 100 mcg Fentanyl recalled by Hospira | Hospira | Sterility | Nationwide |
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Other Carboplatin recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | CARBOplatin Injection 450 mg/ (10 mg/mL) recalled by Mylan Institutional | Mylan Institutional | Particulate Matter | Nationwide |
| Drug | CLASS II | CARBOplatin Injection, 600 mg/, MultiDose recalled | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS I | Carboplatin Injection, 600 mg/ (10 mg/mL), Cytotoxic Agent recalledCarboplatin | Hospira | Particulate Matter | Nationwide |
| Drug | CLASS I | Carboplatin Injection, 450 mg/ (10 mg/mL), Cytotoxic Agent recalledCarboplatin | Hospira | Particulate Matter | Nationwide |
| Drug | CLASS III | Carboplatin Injection, 10 mg/mL, a) multi-dose vials recalled by HospiraCarboplatin | Hospira | Potency & Assay | Nationwide |