Nephron Sterile Compounding Center LLC recalls Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L
Recalled August 24, 2022 · FDA recall D-1345-2022 · Nephron Sterile Compounding Center
Hazard
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. · FDA Class II
Units
294 bags
Sold at
Nationwide in the USA
Description
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Product
Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag, packaged in 1 x 1 IV bag per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-910-04
Manufacturer(s)
Nephron Sterile Compounding Center LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →