Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L
Summary
The FDA issued a Class II for Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/ by Nephron Sterile Compounding Center LLC. Reason: CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing..
Details
Source
Drug Recall
External ID
D-1345-2022
Action Date
2022-08-24
Status
Terminated
Category
drug
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
Lot/Code Info: Lots: TC2007D, Exp. 8/26/2022; TC2010A, Exp. 9/25/2022
Quantity Affected: 294 bags
Reason for Recall
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-10
Company
West Columbia, SC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 61 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Nephron Sterile Compounding Center LLC has 73 FDA actions in our database, including 73 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Nephron Sterile Compounding Center LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Nephron Sterile Compounding Center LLC have FDA actions?
Nephron Sterile Compounding Center LLC has 73 FDA actions in our database, including 73 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1345-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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