IV Trisodium Citrate Solution Recalled for Potential Cross-Contamination Risk
Nephron Sterile Compounding Center is recalling 294 bags of Trisodium Citrate 0.5% Solution IV bags due to potential cross-contamination from manufacturing deviations. The affected lots were distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II IV solution recall with potential cross-contamination from manufacturing deviations. No illnesses or injuries have been reported. Score 3 applies as a risk-of-harm product where actual injury has not yet been reported.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling 294 bags of Trisodium Citrate 0.5% Solution IV bags due to Good Manufacturing Practice (GMP) deviations during the manufacturing process. The affected lots are TC2007D (expires 8/26/2022) and TC2010A (expires 9/25/2022), with product NDC 69374-910-04.
The manufacturer identified potential for cross-contamination due to product carryover between manufacturing batches. This deviation from GMP standards raises concern about the sterility and integrity of the affected intravenous solutions.
The affected product was distributed nationwide across the United States. It is intended for use in clinical and hospital settings as an intravenous infusion.
Healthcare facilities and providers that have received these lot codes should refer to standard recall procedures. Any questions regarding this recall should be directed to Nephron Sterile Compounding Center LLC.
The recalled product
- 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…
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Intravenous Solution
- Affected units
- 294
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lots: TC2007D
- Exp. 8/26/2022
- TC2010A
- Exp. 9/25/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Nephron Sterile Compounding Center LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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