D-1345-2022 Class II Terminated
FDA drug recall D-1345-2022 was initiated by Nephron Sterile Compounding Center LLC on Aug 10, 2022 and is designated Class II. Reason for recall: CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. The recall status is terminated (terminated Oct 11, 2024). Affected quantity: 294 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 24, 2022
- Initiation Date
- Aug 10, 2022
- Termination Date
- Oct 11, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 294 bags
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lots: TC2007D, Exp. 8/26/2022; TC2010A, Exp. 9/25/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1345-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026