United StatesMedicaLyte Liquid Bicarbonate Concentrate (REF: BC-100 lots N4L022, N4L037; BC+201 lot N4L010) and related products MedicaLyte Bicarbonate Powder (REF: DB+201-2.1 lot NDB5E004; DB+201-25 lots NDB5M011, NDB4J003), Citric Complete Dry Citric Acid Concentrate (REF: DCA+200-25, DCA+203-25 with listed lots), and Citric Complete Liquid Citric Acid Concentrate (REF: LC+200-D, LC+201, LC+225 with listed lots) sold nationwide in the US (FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA) and in Guatemala and Panama are being recalled. They were recalled because the hemodialysis concentrates contain high endotoxin levels.
What's being recalled
MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
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)
Recalling firm: Nipro Renal Soultions USA, Corporation, Lewisberry, PA, United States.
How to identify it
BC-100 - Lot:N4L022 (exp.11/13/2026), N4L037(exp.11/18/2026) BC+201- Lot: N4L010(exp.11/06/2026) DB+201-2.1: Lot -NDB5E004(exp.4/30/2027) DB+201-25: Lots - NDB5M011(Exp.12/05/2027, NDB4J003(exp.9/25/2026) DCA+200-25 : Lots - NDC5E015(Exp.5/20/2027), NDC5E016(Exp.5/21/2027), NDC5E017(Exp.5/22/2027), NDC5E019(Exp.5/29/2027), NDC5E012(Exp.5/19/2027), NDC5B017(Exp.2/24/2027), NDC5C023(Exp.3/24/2027) DCA+203-25: NDC5C026(Exp.3/27/2027), NDC5L026(Exp.11/17/2027) LC+200-D: Lot-N4J030 (Exp.9/20/2026), N5D043(Exp.4/16/2027); LC+225: Lot-N6A025(Exp.1/8/2028)
The hazard
Hemodialysis concentrates contain high endotoxin levels
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)