Drug recall
The product is a patient specific allergy treatment set composed of multiple components that are labeled as…
FDA recall event 86652 · Class II · Edge Pharma, LLC
Key facts
| Event ID | 86652 |
|---|---|
| Recall numbers | B-0023-2021 |
| Recalling firm | Edge Pharma, LLC |
| Product type | Biologics |
| Products | The product is a patient specific allergy treatment set composed of multiple components that are labeled as ENV. MIX 1. Container size: 10 mL Number of units packed per shipping carton/case: 5 units |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Edge Pharma's allergy stock vial of Feather Mix, mislabeled as Dog Epithelia, and subsequently used in the preparation of allergy treatment sets, one of which was distributed. |
| Initiation date | Jul 22, 2020 |
| Report date | Nov 25, 2020 |
| Termination date | May 19, 2021 |
| City | Colchester |
| State | VT |
| Country | United States |
| FEI number | 3010490167 |
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: