Drug recall
Brilliant Blue G BBG, 0.025%, Sterile Injection, 0.5 mL Single Dose Vial, Vital Care Compounder, Hattiesburg…
FDA recall event 74539 · Class II · Vital Care Compounder
Key facts
| Event ID | 74539 |
|---|---|
| Recall numbers | D-1054-2016, D-1055-2016, D-1056-2016 |
| Recalling firm | Vital Care Compounder |
| Product type | Drugs |
| Products | Brilliant Blue G BBG, 0.025%, Sterile Injection, 0.5 mL Single Dose Vial, Vital Care Compounder, Hattiesburg, MS, Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9%,1 mL SDV, Vital Care Compounder, Hattiesburg, MS, Trypan Blue 0.3%, 0.5 mL Vial, Vital Care Compounder, Hattiesburg, MS |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials. |
| Initiation date | Jun 10, 2015 |
| Report date | Jul 6, 2016 |
| Termination date | Nov 17, 2016 |
| City | Hattiesburg |
| State | MS |
| Country | United States |
| FEI number | 3010241801 |
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: