Drug recall
ORTHO Sera Papain, Code 6904840, 138 packs each containing 4
FDA recall event 97216 · Class III · ALBA Bioscience Limited
Key facts
| Event ID | 97216 |
|---|---|
| Recall numbers | B-0049-2026 |
| Recalling firm | ALBA Bioscience Limited |
| Product type | Biologics |
| Products | ORTHO Sera Papain, Code 6904840, 138 packs each containing 4 |
| Classification | Class III |
| Status | Completed |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Alba Bioscience is recalling ORTHO Sera Papain (Lot V278742) due to the reactivity that has been confirmed as reduced. Reduced reactivity may result in blood products being administered that result in… |
| Initiation date | Jul 3, 2025 |
| Report date | May 13, 2026 |
| City | Penicuik |
| Country | United Kingdom |
| FEI number | 3011683976 |
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: