The Recall Desk
HighFDA (Drugs)·D-0099-2023·Announced 2023-01-18

Rocuronium Bromide Injection Recalled for Lack of Sterility Assurance

Rocuronium Bromide Injection syringes from Nephron Sterile Compounding Center are being recalled because the manufacturer cannot verify the product is sterile. The recall affects approximately 38,830 pre-filled syringes distributed nationwide.

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 drug recall for lack of sterility assurance in an injectable medication used during anesthesia and critical care. While no reported illnesses or injuries are mentioned, injectable drugs without assured sterility present significant risk of infection, fitting the criterion of risk-of-harm products where injury has not yet been reported.

Plain-English summary

Nephron Sterile Compounding Center LLC is recalling Rocuronium Bromide Injection due to lack of assurance of sterility. Rocuronium Bromide is a neuromuscular blocking agent used during anesthesia and critical care. The product is manufactured by the company's 503B outsourcing facility in West Columbia, South Carolina.

The recalled product is Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) in pre-filled syringes. The affected lot is RC2011A with an expiration date of February 22, 2023. Approximately 38,830 syringes were distributed nationwide in the USA.

Lack of assurance of sterility indicates that the company cannot verify the product meets sterility standards required for injection. Injectable medications must be sterile to prevent infection in patients.

Patients and healthcare providers who possess syringes from this lot should contact Nephron Sterile Compounding Center LLC regarding the recall.

The recalled product

Product
Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-924-05
Manufacturer
Nephron Sterile Compounding Center LLC
Category
Drug — Injectable Drug
Hazard
  • sterility-failure
  • contamination-risk

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 (2)

  • Lot: RC2011A
  • Exp. 2/22/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category