Drug recall
Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct…
FDA recall event 62735 · Class II · Bracco Diagnostics Inc
Key facts
| Event ID | 62735 |
|---|---|
| Recall numbers | D-1665-2012 |
| Recalling firm | Bracco Diagnostics Inc |
| Product type | Drugs |
| Products | Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion, For Intravenous Use, Rx only, a) 50 mL Single Dose Vial, b) 100 mL Single Dose… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage. |
| Initiation date | Apr 16, 2012 |
| Report date | Sep 5, 2012 |
| Termination date | Nov 13, 2013 |
| City | Monroe Township |
| State | NJ |
| Country | United States |
| FEI number | 1000307800 |
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 · Source date: