Drug 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
D-1345-2022
Product summary
- Event
- Event 90718
- Status
- Terminated
- Classification
- Class II
- Quantity
- 294 bags
- Official record key
drug-enforcement:D-1345-2022
Official wording
Reason: CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Code information: Lots: TC2007D, Exp. 8/26/2022; TC2010A, Exp. 9/25/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations