FDA Drug recall 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, p…
- FDA Drug
- Class II
- terminated
- Published 2022-08-24
On 2022-08-24 the FDA classified a Class II recall of 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, p… by Nephron Sterile Compounding Center, citing CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1345-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-08-10 |
| Published | 2022-08-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Nephron Sterile Compounding Center |
| Distribution | US |
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
Reason
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Identifiers
| code_info | Lots: TC2007D, Exp. 8/26/2022; TC2010A, Exp. 9/25/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1345-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.