FDA-Drug2022-08-24Class II
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
Nephron Sterile Compounding Center LLC
Hazard
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Sold states
Nationwide in the USA
Affected count
294 bags
Manufactured in
4500 12th Street Ext, West Columbia, SC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1345-2022Don't want to check this manually?
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