Drug recall
Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: 1) One…
FDA recall event 83511 · Class II · Alkermes Inc
Key facts
| Event ID | 83511 |
|---|---|
| Recall numbers | D-1846-2019 |
| Recalling firm | Alkermes Inc |
| Product type | Drugs |
| Products | Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: 1) One vial of 380 mg of Vivitrol, 2) One vial containing 4 mL of diluent, 3) One 5-mL prepackaged… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not… |
| Initiation date | Aug 8, 2019 |
| Report date | Sep 4, 2019 |
| Termination date | Nov 6, 2020 |
| City | Wilmington |
| State | OH |
| Country | United States |
| FEI number | 1000142940 |
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: