Drug recall
Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use, Sterile…
FDA recall event 74373 · Class II · Sagent Pharmaceuticals Inc
Key facts
| Event ID | 74373 |
|---|---|
| Recall numbers | D-1450-2016 |
| Recalling firm | Sagent Pharmaceuticals Inc |
| Product type | Drugs |
| Products | Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use, Sterile, Nonpyrogenic, Preservative-free, Rx Only, Mfd for Sagent Pharmaceuticals, Schaumberg, IL, 60196, USA… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution. |
| Initiation date | Jun 13, 2016 |
| Report date | Aug 3, 2016 |
| Termination date | Sep 22, 2017 |
| City | Schaumburg |
| State | IL |
| Country | United States |
| FEI number | 3006167046 |
At a glance
- 1–9 Products in this recall
- 1–9 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: