FDA recall D-1345-2022

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 for recall

CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-08-10

Report date

2022-08-24

Termination date

2024-10-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Columbia, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1345-2022