Drug recall
Fosphenytoin Sodium Injection, USP, 50 mg PE/mL, a) 100 mg PE/2 mL vial (NDC 0409-4857-02), b) 100 mg PE/2 mL…
FDA recall event 55551 · Class II · Hospira, Inc.
Key facts
| Event ID | 55551 |
|---|---|
| Recall numbers | D-032-2011 |
| Recalling firm | Hospira, Inc. |
| Product type | Drugs |
| Products | Fosphenytoin Sodium Injection, USP, 50 mg PE/mL, a) 100 mg PE/2 mL vial (NDC 0409-4857-02), b) 100 mg PE/2 mL vial, (NDC 0409-4857-49, Novaplus), c) 500 mg PE/10 mL vial, (NDC 0409-4857-10), d) 500 mg… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of Particulate Matter: The product exceeds the limit of particulate matter allowed by USP <788> |
| Initiation date | Apr 16, 2010 |
| Termination date | Mar 31, 2011 |
| City | Lake Forest |
| State | IL |
| Country | United States |
| FEI number | 3003940565 |
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