Drug recall
Allergen Extract Products - Custom Patient Prescriptions
FDA recall event 85512 · Class II · Edge Pharma, LLC
Key facts
| Event ID | 85512 |
|---|---|
| Recall numbers | B-0063-2021, B-0064-2021 |
| Recalling firm | Edge Pharma, LLC |
| Product type | Biologics |
| Products | Allergen Extract Products - Custom Patient Prescriptions, Allergen Extract Products - Low Dose Antigen |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Edge Pharma's Custom Patient Prescriptions and Low Dose Antigen products, prepared within the cleanroom with multiple environmental monitoring excursions on the day of processing, were distributed. |
| Initiation date | Apr 7, 2020 |
| Report date | Dec 16, 2020 |
| Termination date | Feb 4, 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: