Drug recall
Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) (NDC 61703-360-18, NOVAPLUS), b)…
FDA recall event 62463 · Class III · Hospira Inc.
Key facts
| Event ID | 62463 |
|---|---|
| Recall numbers | D-1648-2012 |
| Recalling firm | Hospira Inc. |
| Product type | Drugs |
| Products | 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH. |
| Initiation date | Jul 2, 2012 |
| Report date | Aug 22, 2012 |
| Termination date | Jul 24, 2017 |
| City | Lake Forest |
| State | IL |
| Country | United States |
| FEI number | 3005579246 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: