CLASS II Drug recall · Reported 24 Aug 2022 · FDA Enforcement Report
Trisodium Citrate 0.5% Solution, (0.5%/, contains Per Liter recalled
Nephron Sterile Compounding Center is recalling Trisodium Citrate 0.5% Solution, (0.5%/, contains Per Liter: Sodium 140 mmol/L, Chloride, distributed nationwide in the US. The recall was initiated on 10 Aug 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1345-2022
- FDA event ID
- 90718
- Recalling firm
- Nephron Sterile Compounding Center, West Columbia, SC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Aug 2022
- FDA classified
- 16 Aug 2022
- Reported
- 24 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Aug 2022 | Recall initiated by company | |
| 16 Aug 2022 | Classified by FDA | +6 days |
| 24 Aug 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Which lots are affected?
Lots: TC2007D, Exp. 8/26/2022; TC2010A, Exp. 9/25/2022
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 90718This product is part of a recall event; the main page for the event is PF-Neostigmine Methylsulfate Injection, USP, 3 mg recalled.
More recalls from Nephron Sterile Compounding Center
All 73| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sodium Chloride Injection 9%, USP, Single-Dose IV recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine HCl Injection, USP, 0.8 mg recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine HCl Injection, USP, 0.4 mg recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |