FDA-Device2026-09-16Class IIPROCESSING DEFECT
Nipro Renal Solutions Citric Complete hemodialysis concentrate recalled for high endotoxin levels
What this means
Nipro Renal Solutions' Citric Complete Liquid Citric Acid Concentrate contains higher-than-safe levels of endotoxins, which are bacterial substances that can cause serious reactions in hemodialysis patients. The affected product was distributed across the US and internationally in specific lot numbers.
- If your dialysis center uses Citric Complete concentrate, contact your provider immediately to verify whether your facility received affected lots.
- Do not use product from the affected lot numbers: LC+200-D lots N4J030 or N5D043; LC+225 lot N6A025.
- Report any adverse reactions or symptoms to your nephrologist or dialysis center right away.
The agency's original wording
Hazard
Hemodialysis concentrates contain high endotoxin levels
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.
Affected count
100 drums/1072 cases
Manufactured in
509 Fishing Creek Rd, Lewisberry, PA, United States
Products
Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3136-2026More Nipro recalls
- FDA-Device2026-09-16Nipro Citric Complete Dry Citric Acid Concentrate recalled for high endotoxin levels
- FDA-Device2026-09-16Nipro MedicaLyte Bicarbonate Powder recalled for high endotoxin levels in hemodialysis concentrate
- FDA-Device2026-09-16Nipro MedicaLyte Liquid Bicarbonate Concentrate recalled for high endotoxin levels in hemodialysis concentrate
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