CLASS I Drug recall · Reported 13 Feb 2013 · FDA Enforcement Report
Carboplatin Injection, 600 mg/ (10 mg/mL), Cytotoxic Agent recalled
Hospira is recalling Carboplatin Injection, 600 mg/ (10 mg/mL), Cytotoxic Agent, Sterile, Multi-Dose Vial, distributed nationwide in the US. The recall was initiated on 8 Nov 2012 and the FDA has classified it as Class I.
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-153-2013
- FDA event ID
- 63548
- Recalling firm
- Hospira, Lake Forest, IL
- Brand
- Carboplatin
- Manufacturer
- Hospira, Inc.
- Classification
- Class I
- Status
- Completed
- Recall initiated
- 8 Nov 2012
- FDA classified
- 6 Feb 2013
- Reported
- 13 Feb 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 8 Nov 2012 | Recall initiated by company | |
| 6 Feb 2013 | Classified by FDA | +90 days |
| 13 Feb 2013 | 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
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
Product as listed by the FDA
Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-56.
Where it was distributed
Nationwide and Puerto Rico.
Questions about this recall
Why was it recalled?
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
Which lots are affected?
Lot #: Z021650AA, Exp. 08/2013
Where was it sold?
Nationwide and Puerto Rico.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 63548This product is part of a recall event; the main page for the event is Carboplatin Injection, 450 mg/ (10 mg/mL), Cytotoxic Agent recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Carboplatin Injection, 450 mg/ (10 mg/mL), Cytotoxic Agent recalledCarboplatin | Hospira | Particulate Matter | Nationwide |
More recalls from Hospira
All 225| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Infant 25% Dextrose Injection recalled by HospiraDextrose | Hospira | Particulate Matter | Nationwide |
| Device | CLASS II | Minibore Extension Set with Spin Lock Collar, Non-DEHP, Latex-Free recalled | Hospira | Other | Nationwide |
| Drug | CLASS III | 5% Lidocaine HCL and 7.5% Dextrose Injection, USP Single-dose ampule recalled | Hospira | Potency & Assay | PR |
| Drug | CLASS II | Fentanyl Citrate Injection, USP, 100 mcg Fentanyl recalled by Hospira | Hospira | Sterility | Nationwide |
| Device | CLASS II | LifeCare PCA 3, PCA recalled by Hospira | Hospira | Device Malfunction | Nationwide |
Other Carboplatin recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carboplatin 174 MG / Ns Ivpb recalled by Infusion Options | Infusion Options | Sterility | NY |
| 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, 450 mg/ (10 mg/mL), Cytotoxic Agent recalledCarboplatin | Hospira | Particulate Matter | Nationwide |
| Drug | CLASS II | Carboplatin Injection, 10 mg/mL Multi-Dose Vial recalled by HospiraCarboplatin | Hospira | Particulate Matter | Nationwide |