Drug recall
Allograft Room Temperature Liquid.5 ML, 1.0ml, 2.0 ml, Catalog ART-13205, 13210, 13220
FDA recall event 95591 · Class II · Dorotea Holding Co, LLC dba Alamo Biologics; dba Precision Allograft Solutions; dba Biorepository, LLC
Key facts
| Event ID | 95591 |
|---|---|
| Recall numbers | B-0162-2025, B-0163-2025, B-0164-2025, B-0165-2025, B-0166-2025 |
| Recalling firm | Dorotea Holding Co, LLC dba Alamo Biologics; dba Precision Allograft Solutions; dba Biorepository, LLC |
| Product type | Biologics |
| Products | Allograft Room Temperature Liquid .5 ML, 1.0ml, 2.0 ml, Catalog ART-13205, 13210, 13220, Amnion Fluid, 2.0 ml, Catalog EAF 20, ProteiOn RT 1.0 ml, 2.0 ml, Catalog AT779RT, AT780RT, ReVIVIFY RT Liquid Amnion 0.5ml, 1.0ml, 2.0ml, Catalog OBS-905, OBS-910, OBS-920, Verafactor Room temp Amnion Fluid 1ml, 2ml, Catalog RTVF100, RTVF200 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Dorotea Holding Co LLC dba Alamo Biologics dba Precision Allograft Solutions dba Biorepository is recalling distributed units of ProteiOn amniotic fluid products that are not the subject of an… |
| Initiation date | Oct 16, 2024 |
| Report date | Feb 19, 2025 |
| City | San Antonio |
| State | TX |
| Country | United States |
| FEI number | 3003279883 |
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: