Drug recall
Ultravist (brand of iopromide) Injection, 370mg I/mL, 50, 75, 100, 125, 150, 200, 250, and 500 mL Sterile…
FDA recall event 35896 · Class I · Berlex Inc
Key facts
| Event ID | 35896 |
|---|---|
| Recall numbers | D-404-7 |
| Recalling firm | Berlex Inc |
| Product type | Drugs |
| Products | Ultravist (brand of iopromide) Injection, 370mg I/mL, 50, 75, 100, 125, 150, 200, 250, and 500 mL Sterile Solution Vials, Rx only, Not for Intrathecal Use, Mfd. for: Berlex, Montville, NJ ---- NDC… |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of precipitate |
| Initiation date | Jul 31, 2006 |
| City | Wayne |
| Country | United States |
| FEI number | 2243252 |
At a glance
- 1–9 Products in this recall
- 10–99 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