Drug recall
VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use…
FDA recall event 65339 · Class II · Sagent Pharmaceuticals Inc
Key facts
| Event ID | 65339 |
|---|---|
| Recall numbers | D-605-2013 |
| Recalling firm | Sagent Pharmaceuticals Inc |
| Product type | Drugs |
| Products | VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195 (USA); Mfd. by MN… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity… |
| Initiation date | Jun 7, 2013 |
| Report date | Jun 26, 2013 |
| Termination date | May 7, 2015 |
| 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: