Agency classClass IIOur severity:High FDA (Drugs)·D-1280-2022·Announced 2022-07-27

Anticoagulant Sodium Citrate Solution Recalled for Sterility Assurance Failure

Nephron Sterile Compounding Center is recalling 85,300 pre-filled syringes of Anticoagulant Sodium Citrate Solution due to failure to assure sterility. Affected patients should contact their healthcare provider.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving injectable medication with a quality control failure in sterility assurance. Although no illnesses or injuries have been reported, unsterile injectable products represent a risk-of-harm scenario that meets the High severity threshold.

Plain-English summary

Nephron Sterile Compounding Center LLC is recalling 85,300 pre-filled syringes of Anticoagulant Sodium Citrate Solution, USP 4% (40 mg/mL), distributed nationwide. The product is supplied in cartons containing 5 pre-filled syringes, with 6 cartons per case.

The recall is due to lack of assurance of sterility. The affected lots were not verified to meet sterility standards required for injectable pharmaceutical products.

Patients, healthcare providers, and facilities using the affected lot numbers (SC2002A through SC2011A, with expiration dates ranging from July 9, 2022 through October 10, 2022) should stop using the product and contact their healthcare provider or Nephron Sterile Compounding Center for instructions.

The recalled product

Product: Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg/5 mL (40 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-906-05
Manufacturer: Nephron Sterile Compounding Center LLC
Category: Drug — Injectable / Anticoagulant
Hazard: sterility-failure
contamination-risk
Affected units: 85,300

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (18)

Lots: SC2002A
Exp. 7/9/2022
SC2004A
Exp. 7/17/2022
SC2005A
Exp. 8/2/2022
SC2006A
Exp. 8/16/2022
SC2007A
Exp. 8/27/2022
SC2008A
Exp. 9/7/2022
SC2009A
Exp. 9/14/2022
SC2010A
Exp. 9/20/2022
SC2011A
Exp. 10/10/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 37 recalled by Nephron Sterile Compounding Center LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 37 products in this recall →

Same manufacturer · Nephron Sterile Compounding Center LLC

See all →

High
Sodium Chloride Injection Recalled for Potential Sterility Compromise
FDA (Drugs) · 2025-03-19
High
Norepinephrine Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-03-08
High
Nephron Phenylephrine HCl Injection Recalled for Sterility Assurance
FDA (Drugs) · 2023-03-08
High
Diltiazem HCl Injectable Drug Recalled for Sterility Assurance Failure
FDA (Drugs) · 2023-03-08
High
FDA Recalls Norepinephrine Injection Due to Sterility Concerns
FDA (Drugs) · 2023-03-08

Same hazard · sterility failure