FDAFDA · Food and drugs·Recall number D-1345-2022
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
Published August 24, 2022 · Recall initiated: August 10, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Distributor
- Nationwide in the USA
- Lot
- Lots: TC2007D, Exp. 8/26/2022; TC2010A, Exp. 9/25/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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