Drug recall
CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Multi-Dose Vial, Rx only…
FDA recall event 70991 · Class I · Mylan Institutional LLC
Key facts
| Event ID | 70991 |
|---|---|
| Recall numbers | D-1331-2015 |
| Recalling firm | Mylan Institutional LLC |
| Product type | Drugs |
| Products | CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Multi-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-493-46, UPC… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of Particulate Matter |
| Initiation date | Mar 18, 2015 |
| Report date | Aug 26, 2015 |
| Termination date | May 19, 2016 |
| City | Rockford |
| State | IL |
| Country | United States |
| FEI number | 3010547225 |
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: