Drug recall
Ondansetron in 5% Dextrose Injection, 32 mg/50 mL (0.64 mg/mL), Single-Dose Premix Bag, Rx only, packaged in 6…
FDA recall event 55848 · Class I · Sagent Pharmaceuticals Inc
Key facts
| Event ID | 55848 |
|---|---|
| Recall numbers | D-694-2010 |
| Recalling firm | Sagent Pharmaceuticals Inc |
| Product type | Drugs |
| Products | Ondansetron in 5% Dextrose Injection, 32 mg/50 mL (0.64 mg/mL), Single-Dose Premix Bag, Rx only, packaged in 6 x 50 mL Premix Bags per case, shipped in 48 (8 cases x 6 bags) x 50 mL Premix Bags per… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Non-Sterility: This product is being recalled because a white feathery substance found floating inside the IV bag was identified as mold. |
| Initiation date | Jun 2, 2010 |
| Termination date | Aug 19, 2011 |
| 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