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
Reported: August 24, 2022 Initiated: August 10, 2022 #D-1345-2022
Product Description
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
Reason for Recall
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Details
- Recalling Firm
- Nephron Sterile Compounding Center LLC
- Units Affected
- 294 bags
- Distribution
- Nationwide in the USA
- Location
- West Columbia, SC
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Nephron Sterile Compounding Center LLC. Units affected: 294 bags.
Why was this product recalled? ▼
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 24, 2022. Severity: Moderate. Recall number: D-1345-2022.
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