Drug recall
Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25
FDA recall event 99573 · Class II · Nipro Renal Soultions USA, Corporation
Key facts
| Event ID | 99573 |
|---|---|
| Recall numbers | Z-3133-2026, Z-3134-2026, Z-3135-2026, Z-3136-2026 |
| Recalling firm | Nipro Renal Soultions USA, Corporation |
| Product type | Devices |
| Products | Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25, Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X), MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X)), MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Hemodialysis concentrates contain high endotoxin levels |
| Initiation date | Aug 5, 2026 |
| Report date | Sep 16, 2026 |
| City | Lewisberry |
| State | PA |
| Country | United States |
| FEI number | 1000142899 |
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: