CLASS III Drug recall · Reported 22 Aug 2012 · FDA Enforcement Report
Carboplatin Injection, 10 mg/mL, a) multi-dose vials recalled by Hospira
Hospira is recalling Carboplatin Injection, 10 mg/mL, a) multi-dose vials (, distributed nationwide in the US. The recall was initiated on 2 Jul 2012 and the FDA has classified it as Class III.
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-1648-2012
- FDA event ID
- 62463
- Recalling firm
- Hospira, Lake Forest, IL
- Brand
- Carboplatin
- Manufacturer
- Hospira, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 2 Jul 2012
- FDA classified
- 16 Aug 2012
- Reported
- 22 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 2 Jul 2012 | Recall initiated by company | |
| 16 Aug 2012 | Classified by FDA | +45 days |
| 22 Aug 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) (NDC 61703-360-18, NOVAPLUS), b) 45 mL multi-dose vials (NDC 61703-339-50) (NDC 61703-360-50 NOVAPLUS), Rx only, Hospira, Inc., Lake Forest, IL 60045, Product of Australia
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Is Carboplatin Injection, 10 mg/mL, a) multi-dose vials ( recalled?
Yes. Hospira recalled Carboplatin Injection, 10 mg/mL, a) multi-dose vials ( on 2 Jul 2012. The recall is Class III and its status is Terminated. Recall number D-1648-2012.
Why was it recalled?
Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.
Which lots are affected?
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 61703-360-50 (Novoplus label), lot number Y061711AA, expiration FEB 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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
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 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 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 II | Carboplatin Injection, 10 mg/mL Multi-Dose Vial recalled by HospiraCarboplatin | Hospira | Particulate Matter | Nationwide |