The Recall Desk
HighFDA (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.

What this means for you

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
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 →

Related recalls

Same manufacturer · Nephron Sterile Compounding Center LLC

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Same hazard · sterility failure

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